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Protocol - Transfusion Reaction Reporting

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Description

This protocol from the SCD-CARRE trial uses existing medical records to determine whether an adverse reaction occurred and whether it was caused by the transfusion. Adverse reactions covered include transfusion associated circulatory overload (TACO), transfusion related acute lung injury (TRALI), transfusion associated dyspnea (TAD), allergic reaction including anaphylaxis, hypotensive transfusion reaction, febrile non-hemolytic transfusion reaction (FNHTR), acute hemolytic transfusion reaction (AHTR), delayed hemolytic transfusion reaction (DHTR), hyper-hemoloysis, delayed serologic transfusion reaction (DSTR), transfusion associated graft versus host disease (TA-GVHD), post transfusion purpura (PTP), and infection. The protocol also captures signs and symptoms, severity, treatment, outcomes, and the blood unit causing the reaction.

Specific Instructions

None

Protocol

Transfusion Reaction

Date and time reaction occurred:

____ - ______ - ____ ___ : ___

dd-mon-yy hh:mm 24h format

Date and time of transfusion:

____ - ______ - ____ ___ : ___

dd-mon-yy hh:mm 24h format

SECTION I. PARTICIPANT INFORMATION

    1. Age: __ (Years)

    2. Gender:

        [ ] Male

        [ ] Female

        [ ] Other Gender Expression

        [ ] Refused

    3. Did the transfusion occur at your facility?

        [ ] Yes

        [ ] No

SECTION II. CASE DEFINITION AND IMPUTABILITY/

1. Transfusion associated circulatory overload (TACO)

A. Case Definition

Check all that occurred within 6 hours of cessation of transfusion (new onset or exacerbation):

        [ ] Acute respiratory distress (dyspnea, orthopnea, cough)

        [ ] Elevated brain natriuretic peptide (BNP)

        [ ] Elevated central venous pressure (CVP)

        [ ] Evidence of left heart failure

        [ ] Evidence of positive fluid balance

        [ ] Radiographic evidence of pulmonary edema

B. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Patient has no other conditions to explain symptoms.

        [ ] There are other potential causes present that could explain symptoms, but transfusion is the most likely cause.

        [ ] Alternate explanations for symptoms are more likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

Does the patient have a history of cardiac insufficiency?

        [ ] Yes, the patient has a history of cardiac insufficiency that could explain the circulatory overload, but transfusion is just as likely to have caused the circulatory overload.

        [ ] Yes, the patient has a history of pre-existing cardiac insufficiency that most likely explains circulatory overload.

        [ ] No, the patient does not have a history of cardiac insufficiency.

Did the patient receive other fluids in addition to the transfusion?

        [ ] Yes

        [ ] No

2. Transfusion related acute lung injury (TRALI)

A. Case Definition

Test Result Positive

Not Done

Negative

Cognate or cross reacting antigen present

No cognate or cross reacting antigen present

Not tested for cognate antigen

Donor or unit HLA Specificity

        [ ]

        [ ]

        [ ]

        [ ]

        [ ]

Donor or unit HNA specificity

        [ ]

        [ ]

        [ ]

        [ ]

        [ ]

Recipient HLA specificity

        [ ]

        [ ]

        [ ]

        [ ]

        [ ]

Recipient HNA specificity

        [ ]

        [ ]

        [ ]

        [ ]

        [ ]

Check all that apply

[ ] NO evidence of acute lung injury (ALI) prior to transfusion.

        [ ] ALI onset during or within 6 hours of cessation of transfusion

        [ ] Hypoxemia – defined as PaO2/FiO2 less than or equal to 300 mm Hg

        [ ] Hypoxemia – defined as Oxygen saturation less than 90% on room air

        [ ] Hypoxemia – defined as Other clinical evidence

        [ ] Radiographic evidence of bilateral infiltrates

        [ ] No evidence of left atrial hypertension (i.e., circulatory overload)

B. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] There are no alternative risk factors for ALI present.

        [ ] There is evidence of other causes for acute lung injury.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

3. Transfusion associated dyspnea (TAD)

Case Definition

Check all that apply

        [ ] Acute respiratory distress occurring within 24 hours of cessation of transfusion.

        [ ] Allergic reaction, TACO, and TRALI definitions are not applicable.

Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Patient has no other conditions that could explain symptoms.

        [ ] There are other potential causes that could explain symptoms, but transfusion is the most likely cause.

        [ ] Other present causes are most likely, but transfusion cannot be ruled out

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

4. Allergic reaction, including anaphylaxis

A. Case Definition

Check the following that occurred during or within 4 hours of cessation of transfusion:

        [ ] Conjunctival edema

        [ ] Edema of lips, tongue and uvula

        [ ] Localized angioedema

        [ ] Erythema and edema of the periorbital area

        [ ] Respiratory distress; bronchospasm

        [ ] Generalized flushing

        [ ] Maculopapular rash

        [ ] Pruritus (itching)

        [ ] Hypotension

        [ ] Urticaria (hives)

B. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] No other evidence of environmental, drug or dietary risks.

        [ ] There are other potential causes present that could explain acute hemolysis, but transfusion is the most likely cause.

        [ ] Other present causes are most likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

When did the reaction occur in relation to the transfusion?

        [ ] Occurred during or within 2 hours of cessation of transfusion.

        [ ] Occurred 2 - 4 hours after cessation of transfusion.

Did the same reaction occur after the transfusion was restarted (rechallenge)?

        [ ] Yes

        [ ] No

5. Hypotensive transfusion reaction

Case Definition

Check all that occurred during or within 1 hour of cessation of transfusion:

        [ ] All other adverse reactions presenting with hypotension are excluded.

        [ ] Hypotension-Drop in systolic BP of greater than or equal to 30 mmHg AND Systolic BP less than or equal to 80 mmHg

Check all that apply:

        [ ] Hypotension occurs, does not meet the criteria above. Other, more specific reaction definitions do not apply.

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] The patient has no other conditions that could explain hypotension.

        [ ] There are other potential causes present that could explain hypotension, but transfusion is the most likely cause.

        [ ] Other conditions that could readily explain hypotension are present.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

How did the patient respond the cessation of transfusion and supportive treatment?

        [ ] Responds rapidly (i.e., within 10 minutes) to cessation of transfusion and supportive treatment.

        [ ] The patient does not respond rapidly to cessation of transfusion and supportive treatment.

When did the reaction occur in relation to the transfusion?

        [ ] Occurs less than 15 minutes after the start of the transfusion.

        [ ] Onset is between 15 minutes after start and 1 hour after cessation of transfusion.

6. Febrile non-hemolytic transfusion reaction (FNHTR)

Case Definition

Check all that occurred during or within 4 hours of cessation of transfusion:

        [ ] Fever (greater than or equal to 38°C/100.4°F oral and a change of at least 1°C/1.8°F) from pre-transfusion value

        [ ] Chills/rigors are present

Check all that apply:

        [ ] FNHTR is suspected, but reported symptoms and/or available information are not sufficient.

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Patient has no other conditions that could explain signs/symptoms.

        [ ] There are other potential causes present that could explain signs/symptoms, but transfusion is the most likely cause.

        [ ] Other present causes are most likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

7. Acute hemolytic transfusion reaction (AHTR)

Case Definition

        [ ] Immune Antibody: ______________

        [ ] Non-immune (specify) ________________________

Check the following that occurred during, or within 24 hours of cessation of transfusion with new onset:

        [ ] Back/flank pain

        [ ] Chills/rigors

        [ ] Epistaxis

        [ ] Disseminated intravascular coagulation (DIC)

        [ ] Oliguria/anuria

        [ ] Hypotension

        [ ] Fever

        [ ] Hematuria (gross visual hemolysis)

        [ ] Pain and/or oozing at IV site

        [ ] Renal failure

        [ ] Other bleeding: _________

Check all that apply:

        [ ] Decreased fibrinogen

        [ ] Decreased haptoglobin

        [ ] Elevated bilirubin

        [ ] Elevated LDH

        [ ] Hemoglobinemia

        [ ] Hemoglobinuria

        [ ] Plasma discoloration c/w hemolysis

        [ ] Spherocytes on blood film

        [ ] Positive direct antiglobulin test (DAT) for anti-IgG or anti-C3

        [ ] Positive elution test with alloantibody present on the transfused red blood cells

        [ ] Serologic testing is negative, and physical cause (e.g., thermal, osmotic, mechanical, chemical) is confirmed.

        [ ] Physical cause is excluded but serologic evidence is not sufficient to meet definitive criteria.

        [ ] Physical cause is suspected and serologic testing is negative.

        [ ] AHTR is suspected, but symptoms, test results, and/or information are not sufficient to confirm reaction

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] ABO or other allotypic RBC antigen incompatibility is known.

        [ ] Only transfusion-related (i.e., immune or non-immune) cause of acute hemolysis is present.

        [ ] There are other potential causes present that could explain acute hemolysis, but transfusion is the most likely cause.

        [ ] Other present causes are most likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

8. Delayed hemolytic transfusion reaction (DHTR)

Case Definition

        [ ] Immune Antibody: ______________

        [ ] Non-immune (specify) ________________________

Check the following that occurred between 24 hours and 28 days after cessation of transfusion:

        [ ] Positive direct antiglobulin test (DAT)

        [ ] Newly-identified red blood cell alloantibody in recipient serum

        [ ] Positive elution test with alloantibody present on the transfused red blood cells

        [ ] Inadequate rise of post-transfusion hemoglobin level or rapid fall in hemoglobin back to pre-transfusion levels

        [ ] Otherwise unexplained appearance of spherocytes

Check if applicable:

        [ ] DHTR is suspected, but reported symptoms, test results, and/or available information are not sufficient

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] No other explanation for symptoms or newly-identified antibody is present.

        [ ] An alternate explanation for symptoms or newly-identified antibody is present, but transfusion is the most likely cause.

        [ ] Other explanations for symptoms or newly-identified antibody are more likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

9. Hyper-hemoloysis

Case Definition

Check all that apply:

        [ ] Severe anemia post-transfusion with post-transfusion hemoglobin value lower than pre-transfusion hemoglobin

        [ ] Evidence of hemolysis (check all that apply):

        [ ] Increased LDH

        [ ] Hemoglobinemia

        [ ] Hemoglobinuria

        [ ] Hyperbilirubinemia

        [ ] Relative reticulocytopenia

        [ ] Presenting symptoms may include fever and VOC post-transfusion

        [ ] Acute form: less than 7 days post-transfusion, with negative DAT and no new RBC allo or auto antibodies identified

        [ ] Delayed form: greater than 7 days post-transfusion, usually with positive DAT and new RBC allo or auto antibodies identified.

Antibody: ______________

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?


[ ] No other explanation for symptoms
[ ] An alternate explanation for symptoms, but transfusion is the most likely cause.
[ ] Other present causes are most likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

10. Delayed serologic transfusion reaction (DSTR)

Case Definition

Antibody(ies):____________________________________________________________

Check all that apply:

        [ ] Absence of clinical or laboratory signs of hemolysis

        [ ] Positive direct antiglobulin test (DAT)

        [ ] Demonstration of new, clinically-significant antibodies against red blood cells

        [ ] Positive antibody screen with newly identified RBC alloantibody

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Transfusion performed by your facility is the only possible cause for seroconversion.

        [ ] The patient has other exposures (e.g. transfusion by another facility or pregnancy) that could explain seroconversion,

but transfusion by your facility is the most likely cause.

        [ ] The patient was transfused by your facility, but other exposures are present that most likely explain seroconversion.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

When did the reaction occur in relation to the transfusion?

        [ ] Occurred between 24 hours and 28 days after cessation of transfusion.

        [ ] Occurred less than 24 hours after cessation of transfusion.

        [ ] Occurred greater than 28 days after cessation of transfusion.

        [ ] No new antibody was identified.

11. Transfusion associated graft vs. host disease (TA-GVHD)

Case Definition

Did patient receive non-irradiated blood product(s) in the two months preceding the reaction?

        [ ] Yes

        [ ] No

Check all that occurred within 2 days to 6 weeks after cessation of transfusion:

        [ ] Diarrhea

        [ ] Fever

        [ ] Hepatomegaly

        [ ] Pancytopenia

        [ ] Liver dysfunction (i.e., elevated ALT, AST, Alkaline phosphatase, and bilirubin)

        [ ] Marrow aplasia

        [ ] Characteristic rash: erythematous, maculopapular eruption centrally that spreads to extremities and may, in severe cases, progress to generalized erythroderma and hemorrhagic bullous formation.

Check all that apply:

        [ ] Characteristic histological appearance of skin or liver biopsy.

        [ ] Biopsy negative or not done.

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] No other alternative diagnoses.

        [ ] Other potential causes are present (e.g., stem cell transplantation).

        [ ] Alternative explanations are more likely (e.g., solid organ transplantation).

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

WBC chimerism:

        [ ] WBC chimerism present

        [ ] WBC chimerism not present or not done

12. Post Transfusion Purpura (PTP)

Case Definition

Check all that occurred after cessation of transfusion:

        [ ] Alloantibodies in the patient directed against HPA or other platelet specific antigen detected at or after development of thrombocytopenia.

        [ ] Thrombocytopenia (i.e., decrease in platelets to less than 20% of pre-transfusion count).

        [ ] Decrease in platelets to levels between 20% and 80% of pre-transfusion count.

Check all that apply:

        [ ] PTP is suspected, but laboratory findings and/or information are not sufficient. NOTE: For example, the patient has a drop in platelet count to less than 80% of pre-transfusion count but HPA antibodies were not tested or were negative.

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Patient has no other conditions to explain thrombocytopenia.

        [ ] There are other potential causes present that could explain thrombocytopenia, but transfusion is the most likely cause.

        [ ] Alternate explanations for thrombocytopenia are more likely, but transfusion cannot be ruled out.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

When did the reaction occur in relation to the transfusion?

        [ ] Occurred 5-12 days post-transfusion.

        [ ] Occurred less than 5 or more than 12 days post-transfusion.

13. Infection

Case Definition

Was a test to detect a specific pathogen performed on the recipient post-transfusion?

        [ ] Yes

        [ ] No

If Yes, positive or reactive results?

        [ ] Yes

        [ ] No

Org1 ____________________

Org2 ____________________

Org3 ____________________

Was a test to detect a specific pathogen performed on the donor post-donation?

        [ ] Yes

        [ ] No

If Yes, positive or reactive results?

        [ ] Yes

        [ ] No

Org1 ____________________

Org2 ____________________

Org3 ____________________

Was a test to detect a specific pathogen performed on the unit post-transfusion?

(i.e., culture, serology, NAT)

        [ ] Yes

        [ ] No

If Yes, positive or reactive results?

        [ ] Yes

        [ ] No

Org1 ____________________

Org2 ____________________

Org3 ____________________

Check all that apply:

        [ ] Temporally associated unexplained clinical illness consistent with infection

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] No other potential exposures to the pathogen could be identified in the recipient.

        [ ] Evidence is clearly in favor of a cause other than transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

Check all that apply:

        [ ] Evidence of the pathogen in the transfused component.

        [ ] Evidence of the pathogen in the donor at the time of donation.

        [ ] Evidence of the pathogen in an additional component from the same donation.

        [ ] Evidence of the pathogen in an additional recipient of a component from the same donation.

        [ ] Evidence that the identified pathogen strains are related by molecular or extended phenotypic comparison testing with statistical confidence (p<0.05).

        [ ] Evidence that the transfused component was negative for this pathogen at the time of transfusion

        [ ] Evidence that the donor was negative for this pathogen at the time of donation.

        [ ] Evidence that additional components from the same donation were negative for this pathogen.

        [ ] Evidence that the recipient was not infected with the pathogen prior to transfusion.

        [ ] Laboratory evidence that the recipient was infected with this pathogen prior to transfusion

    14. Other, specify: __________________________________________________________

14. Case Definition

List tests relevant to reaction investigation:

Test name: ________________

Testing date: _______________

Test result: _________________

Test name: ________________

Testing date: _______________

Test result: _________________

    2. Imputability

Which best describes the relationship between the transfusion and the reaction?

        [ ] Conclusive evidence exists that the adverse reaction can be attributed to the transfusion.

        [ ] Evidence is clearly in favor of attributing the adverse reaction to the transfusion.

        [ ] Evidence is indeterminate for attributing the adverse reaction to the transfusion or an alternate cause.

        [ ] Evidence is clearly in favor of a cause other than the transfusion, but transfusion cannot be excluded.

        [ ] There is conclusive evidence beyond reasonable doubt of a cause other than the transfusion.

        [ ] The relationship between the adverse reaction and the transfusion is unknown or not stated.

SECTION III. OTHER SIGNS AND SYMPTOMS

Check all that apply:

Generalized:

        [ ] Chills/rigors

        [ ] Fever

        [ ] Nausea/vomiting

Cardiovascular:

        [ ] Blood pressure decrease

        [ ] Shock

Cutaneous:

        [ ] Edema

        [ ] Other Rash

        [ ] Flushing

        [ ] Pruritus (itching)

        [ ] Jaundice

        [ ] Urticaria (hives)

Hemolysis:

        [ ] Disseminated intravascular coagulation

        [ ] Hemoglobinemia

        [ ] Positive antibody screen

Pain:

        [ ] Abdominal pain

        [ ] Back pain

        [ ] Flank Pain

        [ ] Infusion Site Pain

Renal:

        [ ] Hematuria

        [ ] Hemoglobinuria

        [ ] Oliguria

        [ ] Bleeding

Respiratory:

        [ ] Bilateral infiltrates on chest x-ray

        [ ] Hypoxemia

        [ ] Bronchospasm

        [ ] Shortness of breath

        [ ] Cough

Other, specify: ____________________________________________________________

SECTION IV. SEVERITY [ ] Not determined (for Delayed Serologic Transfusion Reaction (DSTR))

Did the patient receive or experience any of the following?

        [ ] No treatment required

        [ ] Symptomatic treatment only

        [ ] Hospitalization, including prolonged hospitalization

        [ ] Life-threatening reaction

        [ ] Disability and/or incapacitation

        [ ] Congenital anomaly or birth defect(s) of the fetus

        [ ] Other medically important conditions

        [ ] Death

        [ ] Unknown or not stated

SECTION V. PATIENT TREATMENT

Did the patient receive treatment for the transfusion reaction?

        [ ] No

        [ ] Yes

        [ ] Unknown

If yes, select treatment(s):

        [ ] Medication (Select the type of medication)

        [ ] Antipyretics

        [ ] Antihistamines

        [ ] Inotropes/Vasopressors

        [ ] Bronchodilator

        [ ] Diuretics

        [ ] Intravenous Immunoglobulin

        [ ] Intravenous steroids

        [ ] Corticosteroids

        [ ] Antibiotics

        [ ] Anti-thymocyte globulin

        [ ] Cyclosporin

        [ ] Other

        [ ] Volume resuscitation (Intravenous colloids or crystalloids)

        [ ] Respiratory support (Select the type of support)

        [ ] Mechanical ventilation

        [ ] Noninvasive ventilation

        [ ] Oxygen

        [ ] Renal replacement therapy (Select the type of therapy)

        [ ] Hemodialysis

        [ ] Peritoneal

        [ ] Continuous Veno-Venous Hemofiltration

        [ ] Phlebotomy

        [ ] Other, Specify: ____________________________________________________________

SECTION VI. OUTCOME

        [ ] Death

        [ ] Major or long-term sequelae

        [ ] Minor or no sequelae

        [ ] Not determined

If recipient died,

    1.1 Date of Death (dd-mon-yy): ____ - ______ - ____

    1.2 Relationship of transfusion to death:

        [ ] Definite

        [ ] Probable

        [ ] Possible

        [ ] Doubtful

        [ ] Ruled Out

        [ ] Not determined

    1.3 Cause of death: __________________________________________________________

    1.4 Was an autopsy performed?

        [ ] Yes

        [ ] No

SECTION VII. COMPONENT DETAILS

Was a particular unit implicated in (i.e., responsible for) the adverse reaction?

        [ ] Yes

        [ ] No

        [ ] N/A

Transfusion Start and End Date and Time

(dd-mon-yy hh:mm)

Component code

(check system used)

Amount transfused at reaction onset

Blood Unit number

Unit expiration Date and Time

(dd-mon-yy hh:mm)

Implicated Unit?

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Complete page 4 to report more units implicated in this adverse reaction.

SECTION VIII. CUSTOM FIELDS

Label

Label

_______________ ___- _____-___ (dd-mon-yy)

_______________ ___- _____-___ (dd-mon-yy)

_______________ ___________________

_______________ ___________________

Comments

Complete the Serious Adverse Event (SAE) form for this reaction within 24 hours of diagnosis

SECTION VII. COMPONENT DETAILS (continued)

Transfusion Start and End Date and Time

(dd-mon-yy hh:mm)

Component code

(check system used)

Amount transfused at reaction onset

Blood Unit number

Unit expiration Date and Time

(dd-mon-yy hh:mm)

Implicated Unit?

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Start: ___- _____-___

____ : ____

End: ___- _____-___

____ : ____

        [ ] ISBT-128

        [ ] Codabar

_________________

        [ ] Entire unit

        [ ] Partial unit

______mL

__________

___- _____-___

____ : ____

        [ ] Yes

        [ ] No

Availability

Available

Personnel and Training Required

Personnel who are trained in performing medical records review

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Medical record abstraction

Lifestage

Infant, Toddler, Child, Adolescent, Adult

Participants

Patients who had adverse transfusion reactions

Selection Rationale

The Sickle Cell Disease Curative Therapies Working Group selected questions from the Sickle Cell Disease and Cardiovascular Risk—Red Cell Exchange (SCD-CARRE) as the best standardized methodology for collecting data on transfusion reactions. 

Language

English

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Acute Graft Versus Host Disease Other Anatomic Site Involvement Occurrence Specify Text 5040187 CDE Browser
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

The Sickle Cell Disease and Cardiovascular Risk—Red Cell Exchange Trial (SCD CARRE)

Source

National Heart, Lung, and Blood Institute. (2020). Sickle Cell Disease and CardiovAscular Risk—Red Cell Exchange (Version 1.0).

General References

Chou, S T., Alsawas, M., Fasano, R. M., Field, J. J., Hendrickson, J. E., Howard, J., Kameka, M., Kwiatkowski, J. L., Pirenne, F., Shi, P. A., Stowell, S. R., Thein, S. L., Westhoff, C. M., Wong, T. E., & Akl, E. A. (2020). American Society of Hematology 2020 guidelines for sickle cell disease: Transfusion support. Blood Advances, 4(2), 327–355.

U.S. Centers for Disease Control and Prevention. (2021). National Healthcare Safety Network Biovigilance Component: Hemovigilance Module surveillance protocol (Version 2.5). Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases. http://www.cdc.gov/nhsn/PDFs/Biovigilance/BV-HV-protocol-current.pdf

Protocol ID

851001

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case
PX851001270000 Case Definition N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case_All
PX851001290000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case_Cessation
PX851001280000 Check the following that occurred during, or more
within 24 hours of cessation of transfusion with new onset: show less
N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case_Cessation_Other
PX851001280100 Check the following that occurred during, or more
within 24 hours of cessation of transfusion with new onset- Other bleeding show less
N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case_Immune
PX851001270100 Case Definition Immune Antibody N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Case_Nonimmune
PX851001270200 Case Definition Non-immune (specify) N/A
PX851001_Transfusion_Reaction_Acute_Hemolytic_Imputability
PX851001300000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Case_Donor_HLA
PX851001100100 Donor or unit HLA Specificity N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Case_Donor_HNA
PX851001100200 Donor or unit HNA specificity N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Case_Recipient_All
PX851001110000 Check all that apply N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Case_Recipient_HLA
PX851001100300 Recipient HLA specificity N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Case_Recipient_HNA
PX851001100400 Recipient HNA specificity N/A
PX851001_Transfusion_Reaction_Acute_Lung_Injury_Imputability
PX851001120000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Allergic_Reaction_Case
PX851001150000 Check the following that occurred during or more
within 4 hours of cessation of transfusion: show less
N/A
PX851001_Transfusion_Reaction_Allergic_Reaction_Imputability_Reaction
PX851001170000 When did the reaction occur in relation to more
the transfusion? show less
N/A
PX851001_Transfusion_Reaction_Allergic_Reaction_Imputability_Relationship
PX851001160000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Allergic_Reaction_Imputability_Restart
PX851001180000 Did the same reaction occur after the more
transfusion was restarted (rechallenge)? show less
N/A
PX851001_Transfusion_Reaction_Circulatory_Overload_Case
PX851001060000 Check all that occurred within 6 hours of more
cessation of transfusion (new onset or exacerbation): show less
N/A
PX851001_Transfusion_Reaction_Circulatory_Overload_Imputability_Cardiac
PX851001080000 Does the patient have a history of cardiac more
insufficiency? show less
N/A
PX851001_Transfusion_Reaction_Circulatory_Overload_Imputability_Fluids
PX851001090000 Did the patient receive other fluids in more
addition to the transfusion? show less
N/A
PX851001_Transfusion_Reaction_Circulatory_Overload_Imputability_Relationship
PX851001070000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_1
PX851001710105 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_10
PX851001730605 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_11
PX851001730705 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_2
PX851001710205 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_3
PX851001710305 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_4
PX851001710405 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_5
PX851001730105 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_6
PX851001730205 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_7
PX851001730305 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_8
PX851001730405 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_9
PX851001730505 Amount transfused at reaction onset N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_1
PX851001710106 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_10
PX851001730606 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_11
PX851001730706 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_2
PX851001710206 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_3
PX851001710306 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_4
PX851001710406 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_5
PX851001730106 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_6
PX851001730206 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_7
PX851001730306 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_8
PX851001730406 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Amount_Partial_9
PX851001730506 Amount transfused at reaction onset Partial more
unit (mL) show less
N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_1
PX851001710107 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_10
PX851001730607 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_11
PX851001730707 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_2
PX851001710207 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_3
PX851001710307 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_4
PX851001710407 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_5
PX851001730107 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_6
PX851001730207 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_7
PX851001730307 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_8
PX851001730407 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Blood_Unit_9
PX851001730507 Blood Unit number N/A
PX851001_Transfusion_Reaction_Component_Component_1
PX851001710103 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_10
PX851001730603 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_11
PX851001730703 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_2
PX851001710203 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_3
PX851001710303 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_4
PX851001710403 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_5
PX851001730103 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_6
PX851001730203 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_7
PX851001730303 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_8
PX851001730403 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_9
PX851001730503 Component code (check system used) N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_1
PX851001710104 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_10
PX851001730604 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_11
PX851001730704 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_2
PX851001710204 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_3
PX851001710304 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_4
PX851001710404 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_5
PX851001730104 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_6
PX851001730204 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_7
PX851001730304 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_8
PX851001730404 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_Component_Codabar_9
PX851001730504 Component code (check system used) Codabar N/A
PX851001_Transfusion_Reaction_Component_End_1
PX851001710102 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_10
PX851001730602 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_11
PX851001730702 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_2
PX851001710202 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_3
PX851001710302 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_4
PX851001710402 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_5
PX851001730102 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_6
PX851001730202 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_7
PX851001730302 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_8
PX851001730402 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_End_9
PX851001730502 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) End: show less
N/A
PX851001_Transfusion_Reaction_Component_Expiration_1
PX851001710108 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_10
PX851001730608 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_11
PX851001730708 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_2
PX851001710208 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_3
PX851001710308 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_4
PX851001710408 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_5
PX851001730108 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_6
PX851001730208 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_7
PX851001730308 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_8
PX851001730408 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Expiration_9
PX851001730508 Unit expiration Date and Time (dd-mon-yy hh:mm) N/A
PX851001_Transfusion_Reaction_Component_Implicated_1
PX851001710109 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_10
PX851001730609 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_11
PX851001730709 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_2
PX851001710209 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_3
PX851001710309 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_4
PX851001710409 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_5
PX851001730109 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_6
PX851001730209 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_7
PX851001730309 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_8
PX851001730409 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Implicated_9
PX851001730509 Implicated Unit? N/A
PX851001_Transfusion_Reaction_Component_Start_1
PX851001710101 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_10
PX851001730601 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_11
PX851001730701 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_2
PX851001710201 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_3
PX851001710301 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_4
PX851001710401 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_5
PX851001730101 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_6
PX851001730201 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_7
PX851001730301 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_8
PX851001730401 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Start_9
PX851001730501 Transfusion Start and End Date and Time more
(dd-mon-yy hh:mm) Start: show less
N/A
PX851001_Transfusion_Reaction_Component_Unit
PX851001710000 Was a particular unit implicated in (i.e., more
responsible for) the adverse reaction? show less
N/A
PX851001_Transfusion_Reaction_Custom_Fields_Comments_1
PX851001720103 Comments N/A
PX851001_Transfusion_Reaction_Custom_Fields_Comments_2
PX851001720203 Comments N/A
PX851001_Transfusion_Reaction_Custom_Fields_Label_1
PX851001720102 Label N/A
PX851001_Transfusion_Reaction_Custom_Fields_Label_2
PX851001720202 Label N/A
PX851001_Transfusion_Reaction_Custom_Fields_Label_Date_1
PX851001720101 Label (dd-mon-yy) N/A
PX851001_Transfusion_Reaction_Custom_Fields_Label_Date_2
PX851001720201 Label (dd-mon-yy) N/A
PX851001_Transfusion_Reaction_Date_Reaction_Occur
PX851001010000 Date and time reaction occurred (dd-mon-yy more
hh:mm 24h format): show less
N/A
PX851001_Transfusion_Reaction_Date_Reaction_Transfusion
PX851001020000 Date and time of transfusion (dd-mon-yy more
hh:mm 24h format): show less
N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case
PX851001310000 Case Definition N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case_Cessation
PX851001320000 Check the following that occurred between 24 more
hours and 28 days after cessation of transfusion: show less
N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case_Immune
PX851001310100 Case Definition Immune Antibody N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case_Imputability
PX851001340000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case_Nonimmune
PX851001310200 Case Definition Non-immune (specify) N/A
PX851001_Transfusion_Reaction_Delayed_Hemolytic_Case_Suspect
PX851001330000 Check if applicable: N/A
PX851001_Transfusion_Reaction_Delayed_Serologic_Case_All
PX851001370200 Check all that apply: N/A
PX851001_Transfusion_Reaction_Delayed_Serologic_Case_Antibody
PX851001370100 Antibody(ies): N/A
PX851001_Transfusion_Reaction_Delayed_Serologic_Imputability_Reaction
PX851001390000 When did the reaction occur in relation to more
the transfusion? show less
N/A
PX851001_Transfusion_Reaction_Delayed_Serologic_Imputability_Relationship
PX851001380000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Dyspnea_Case
PX851001130000 Check all that apply N/A
PX851001_Transfusion_Reaction_Dyspnea_Imputability
PX851001140000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Febrile_Nonhemolytic_All
PX851001250000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Febrile_Nonhemolytic_Case_Cessation
PX851001240000 Check all that occurred during or within 4 more
hours of cessation of transfusion: show less
N/A
PX851001_Transfusion_Reaction_Febrile_Nonhemolytic_Imputability
PX851001260000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Graft_Host_Case_All
PX851001420000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Graft_Host_Case_Cessation
PX851001410000 Check all that occurred within 2 days to 6 more
weeks after cessation of transfusion: show less
N/A
PX851001_Transfusion_Reaction_Graft_Host_Case_Product
PX851001400000 Did patient receive non-irradiated blood more
product(s) in the two months preceding the reaction? show less
N/A
PX851001_Transfusion_Reaction_Graft_Host_Imputability_Chimerism
PX851001440000 WBC chimerism: N/A
PX851001_Transfusion_Reaction_Graft_Host_Imputability_Relationship
PX851001430000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Hyperhemoloysis_Case_All
PX851001350000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Hyperhemoloysis_Case_Antibody
PX851001350100 Check all that apply Antibody N/A
PX851001_Transfusion_Reaction_Hyperhemoloysis_Imputability
PX851001360000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Hypotensive_Transfusion_Case_All
PX851001200000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Hypotensive_Transfusion_Case_Cessation
PX851001190000 Check all that occurred during or within 1 more
hour of cessation of transfusion: show less
N/A
PX851001_Transfusion_Reaction_Hypotensive_Transfusion_Imputability_Reaction
PX851001230000 When did the reaction occur in relation to more
the transfusion? show less
N/A
PX851001_Transfusion_Reaction_Hypotensive_Transfusion_Imputability_Relationship
PX851001210000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Hypotensive_Transfusion_Imputability_Response
PX851001220000 How did the patient respond the cessation of more
transfusion and supportive treatment? show less
N/A
PX851001_Transfusion_Reaction_Infection_All
PX851001520000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Infection_Donation
PX851001500000 Was a test to detect a specific pathogen more
performed on the donor post-donation? show less
N/A
PX851001_Transfusion_Reaction_Infection_Donation_Reactive
PX851001500100 If Yes, positive or reactive results? N/A
PX851001_Transfusion_Reaction_Infection_Donation_Reactive_Org_1
PX851001500101 If Yes, positive or reactive results? Org1 N/A
PX851001_Transfusion_Reaction_Infection_Donation_Reactive_Org_2
PX851001500102 If Yes, positive or reactive results? Org2 N/A
PX851001_Transfusion_Reaction_Infection_Donation_Reactive_Org_3
PX851001500103 If Yes, positive or reactive results? Org3 N/A
PX851001_Transfusion_Reaction_Infection_Imputability
PX851001530000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Infection_Imputability_All
PX851001540000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Infection_Transfusion
PX851001490000 Was a test to detect a specific pathogen more
performed on the recipient post-transfusion? show less
N/A
PX851001_Transfusion_Reaction_Infection_Transfusion_Reactive
PX851001490100 If Yes, positive or reactive results? N/A
PX851001_Transfusion_Reaction_Infection_Transfusion_Reactive_Org_1
PX851001490101 If Yes, positive or reactive results? Org1 N/A
PX851001_Transfusion_Reaction_Infection_Transfusion_Reactive_Org_2
PX851001490102 If Yes, positive or reactive results? Org2 N/A
PX851001_Transfusion_Reaction_Infection_Transfusion_Reactive_Org_3
PX851001490103 If Yes, positive or reactive results? Org3 N/A
PX851001_Transfusion_Reaction_Infection_Unit
PX851001510000 Was a test to detect a specific pathogen more
performed on the unit post-transfusion? (i.e., culture, serology, NAT) show less
N/A
PX851001_Transfusion_Reaction_Infection_Unit_Reactive
PX851001510100 If Yes, positive or reactive results? N/A
PX851001_Transfusion_Reaction_Infection_Unit_Reactive_Org_1
PX851001510101 If Yes, positive or reactive results? Org1 N/A
PX851001_Transfusion_Reaction_Infection_Unit_Reactive_Org_2
PX851001510102 If Yes, positive or reactive results? Org2 N/A
PX851001_Transfusion_Reaction_Infection_Unit_Reactive_Org_3
PX851001510103 If Yes, positive or reactive results? Org3 N/A
PX851001_Transfusion_Reaction_Other
PX851001550000 Other, specify: N/A
PX851001_Transfusion_Reaction_Other_Test_Date_1
PX851001560102 List tests relevant to reaction more
investigation -Testing date: show less
N/A
PX851001_Transfusion_Reaction_Other_Test_Date_2
PX851001560202 List tests relevant to reaction more
investigation -Testing date: show less
N/A
PX851001_Transfusion_Reaction_Other_Test_Name_1
PX851001560101 List tests relevant to reaction more
investigation -Test name: show less
N/A
PX851001_Transfusion_Reaction_Other_Test_Name_2
PX851001560201 List tests relevant to reaction more
investigation -Test name: show less
N/A
PX851001_Transfusion_Reaction_Other_Test_Result_1
PX851001560103 List tests relevant to reaction more
investigation -Test result: show less
N/A
PX851001_Transfusion_Reaction_Other_Test_Result_2
PX851001560203 List tests relevant to reaction more
investigation -Test result: show less
N/A
PX851001_Transfusion_Reaction_Other__Imputability
PX851001570000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Outcome
PX851001690000 OUTCOME N/A
PX851001_Transfusion_Reaction_Outcome_Autopsy
PX851001700400 If recipient died, Was an autopsy performed? N/A
PX851001_Transfusion_Reaction_Outcome_Cause
PX851001700300 If recipient died, Cause of death: N/A
PX851001_Transfusion_Reaction_Outcome_Date_Death
PX851001700100 If recipient died, Date of Death (dd-mon-yy): N/A
PX851001_Transfusion_Reaction_Outcome_Relationship
PX851001700200 If recipient died, Relationship of more
transfusion to death: show less
N/A
PX851001_Transfusion_Reaction_Participant_Age
PX851001030000 Age (Years): N/A
PX851001_Transfusion_Reaction_Participant_Facility
PX851001050000 Did the transfusion occur at your facility? N/A
PX851001_Transfusion_Reaction_Participant_Gender
PX851001040000 Gender: N/A
PX851001_Transfusion_Reaction_Purpura_All
PX851001460000 Check all that apply: N/A
PX851001_Transfusion_Reaction_Purpura_Cessation
PX851001450000 Check all that occurred after cessation of more
transfusion: show less
N/A
PX851001_Transfusion_Reaction_Purpura_Reaction
PX851001480000 When did the reaction occur in relation to more
the transfusion? show less
N/A
PX851001_Transfusion_Reaction_Purpura_Relationship
PX851001470000 Which best describes the relationship more
between the transfusion and the reaction? show less
N/A
PX851001_Transfusion_Reaction_Severity
PX851001660000 SEVERITY N/A
PX851001_Transfusion_Reaction_Severity_Any
PX851001670000 Did the patient receive or experience any of more
the following? show less
N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Cardiovascular
PX851001590000 Cardiovascular: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Cutaneous
PX851001600000 Cutaneous: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Generalized
PX851001580000 Generalized: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Hemolysis
PX851001610000 Hemolysis: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Other
PX851001650000 Other, specify: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Pain
PX851001620000 Pain: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Renal
PX851001630000 Renal: N/A
PX851001_Transfusion_Reaction_Signs_Symptoms_Respiratory
PX851001640000 Respiratory: N/A
PX851001_Transfusion_Reaction_Treatment
PX851001680100 If yes, select treatment(s): N/A
PX851001_Transfusion_Reaction_Treatment_Medication
PX851001680101 If yes, select treatment(s) -Medication more
(Select the type of medication) show less
N/A
PX851001_Transfusion_Reaction_Treatment_Other
PX851001680104 If yes, select treatment(s) -Other, Specify: N/A
PX851001_Transfusion_Reaction_Treatment_Renal
PX851001680103 If yes, select treatment(s) -Renal more
replacement therapy (Select the type of therapy) show less
N/A
PX851001_Transfusion_Reaction_Treatment_Respiratory
PX851001680102 If yes, select treatment(s) - Respiratory more
support (Select the type of support) show less
N/A
PX851001_Transfusion_Reaction_Treatment_Transfusion
PX851001680000 Did the patient receive treatment for the more
transfusion reaction? show less
N/A
Curative Therapies
Measure Name

Transfusion Reaction Reporting

Release Date

August 16, 2021

Definition

A transfusion reaction occurs when there is an adverse response to a blood transfusion.

Purpose

Transfusion reactions include infectious and non-infectious reactions such as acute hemolytic transfusion reactions (AHTRs), delayed hemolytic transfusion reactions (DHTRs), delayed serologic transfusion reactions (DSTRs), allergic reactions, transfusion related acute lung injury (TRALI), transfusion associated circulatory overload (TACO), and transfusion associated graft versus host disease. Some transfusion reactions (e.g., DSTRs and DHTRs) are more common in patients with sickle cell disease (SCD) compared to the general population.

Keywords

Sickle cell disease, SCD, transfusion, blood transfusion, transfusion reaction, red cell exchange.

Measure Protocols
Protocol ID Protocol Name
851001 Transfusion Reaction Reporting
Publications

There are no publications listed for this protocol.