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Protocol - History of Transfusion

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Description:

This protocol includes three self-administered questions from the Duke-UNC-Emory Outcome Modifying Genes Study that capture number of units (pints) of blood ever received, whether the patient is currently receiving chronic transfusion therapy, and whether the patient is on iron chelation treatment.

Protocol:

1. Estimate the number of units (pints) of blood that you have ever received. (Select one).

[ ] none

[ ] 1 to 10

[ ] 11 to 20

[ ] 21 to 50

[ ] more than 50

[ ] Don’t Know

2. Are you on chronic transfusion therapy at this time?

[ ] Yes

[ ] No

[ ] Don’t Know

3. Are you on iron chelation treatment?

[ ] Yes

[ ] No

[ ] Don’t Know

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required

None

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

Self-administered questionnaire

Life Stage:

Adult

Participants:

Adults, ages 18 and older

Specific Instructions:

Although these questions were originally administered to adults, the Sickle Cell Disease Research and Scientific Panel (SRSP) notes that they could be administered to other age groups, such as senior citizens, adolescents, or young children via proxy.

The SRSP notes that units, pints, or bags of blood may be used interchangeably in question 1, and that the investigator should use whichever term is more likely to be understood by the patient.

The SRSP notes that it may be helpful to give the participant a list of medications used for iron chelation, such as Deferoxamine (Desferal®), Deferasirox (Exjade™), or Deferiprone (Ferriprox®).

Desferal® is a registered trademark of Novartis Pharmaceuticals Corporation.

Exjade™ is a trademark of Novartis Pharmaceuticals Corporation.

Ferriprox® is a registered trademark of Apotex technologies Inc.

Selection Rationale

The brief, low-burden, self-administered questions from the Duke-UNC-Emory Outcome Modifying Genes Study were vetted against transfusion assessments from several clinical trials and were chosen as the best available method to capture the relevant data.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Hematology Blood Transfusion History Questionnaire Assessment Text 4924426 CDE Browser
Derived Variables

None

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Telen, M.J., Afenyi-Annan, A., Garrett, M.E., Combs, M.R., Orringer, E.P., & Ashley-Koch, A.E. (2015). Alloimmunization in sickle cell disease: changing antibody specificities and association with chronic pain and decreased survival. Transfusion 55(6 Pt 2), 1378 - 1387.

General References

Detterich, J.A., Kato, R.M., Rabai, M., Meiselman, H.J., Coates, T.D., & Wood, J.C. (2015). Chronic transfusion therapy improves but does not normalize systemic and pulmonary vasculopathy in sickle cell disease. pii: blood-2014-12-614370. [Epub ahead of print]

Kassim, A.A., Galadanci, N.A., Pruthi, S., & DeBaun, M.R. (2015). How I treat and manage strokes in sickle cell disease. Blood 125(22), 3401-3410.

Kwiatkowski, J.L., Yim, E., Miller, S., Adams, R.J.; STOP 2 Study Investigators. (2011). Effect of transfusion therapy on transcranial Doppler ultrasonography velocities in children with sickle cell disease. Pediatric Blood and Cancer 56(5), 777-782.

Protocol ID:

830201

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX830201_Transfusion_Chronic_Therapy PX830201020000 Are you on chronic transfusion therapy at this time? 4 N/A
PX830201_Transfusion_Iron_Chelation PX830201030000 Are you on iron chelation treatment? 4 N/A
PX830201_Transfusion_Lifetime PX830201010000 Estimate the number of units (pints) of blood that you have ever received. (Select one). 4 N/A
Research Domain Information
Measure Name:

History of Transfusion

Release Date:

July 30, 2015

Definition

A questionnaire to assess history of transfusion.

Purpose

Blood transfusions, which are used to treat various medical conditions such as hemophilia, cancer, and sickle cell disease, expose patients to risks of infectious agents (e.g., HIV and hepatitis), iron overload, alloimmunization and hyperviscosity. Transfusion therapy can also impact the results of bioassays, such as complete blood count, reticulocyte count, cell-free hemoglobin, haptoglobin, aspartate aminotransferase, and measurements such as transcranial Doppler ultrasonography (TCD).

Keywords

Sickle cell disease, SCD, transfusion, blood transfusion, chronic transfusion, iron chelation, transfusion history, hemophilia, hemochromatosis, HIV, AIDS, hepatitis, red cell exchange, erythrocytapheresis,