Protocol - History of Transfusion
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.
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.
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
Personnel and Training Required
|Specialized requirements for biospecimen collection||No|
|Average time of greater than 15 minutes in an unaffected individual||No|
Mode of Administration
Adults, ages 18 and older
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.
|caDSR Form||PhenX PX830201 - History Of Transfusion||6254765||caDSR Form|
Process and Review
Protocol Name from Source
Telen, M.J., et al. Alloimmunization in sickle cell disease: changing antibody specificities and association with chronic pain and decreased survival. TRANSFUSION, 2015
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.
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.
|Variable Name||Variable ID||Variable Description||dbGaP Mapping|
|PX830201020000||Are you on chronic transfusion therapy at more||N/A|
|PX830201030000||Are you on iron chelation treatment?||N/A|
|PX830201010000||Estimate the number of units (pints) of more||N/A|
History of Transfusion
July 30, 2015
A questionnaire to assess history of transfusion.
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).
history of transfusion, sickle cell disease, SCD, transfusion, blood transfusion, chronic transfusion, iron chelation, transfusion history, hemophilia, hemochromatosis, HIV, AIDS, hepatitis, red cell exchange, erythrocytapheresis,
|Protocol ID||Protocol Name|
|830201||History of Transfusion|
Glassberg, J. A., et al. (2020) Publication of data collection forms from NHLBI funded sickle cell disease implementation consortium (SCDIC) registry. Orphanet J Rare Dis. 2020 July; 15(1): 178. doi: 10.1186/s13023-020-01457-x