Myelodysplastic Syndrome Clinical Trial
— UDOfficial title:
Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes
NCT number | NCT04859218 |
Other study ID # | UD_3414 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2023 |
Est. completion date | December 2024 |
In a recent analysis of a large transfusion database (Transfusion Research Utilization, Surveillance and Tracking database [TRUST]), the investigators found that the transfusion of ABO non-identical RBCs to group A individual was associated with an increased risk of death in-hospital compared to patients transfused with ABO identical RBCs (Red Blood Cells). Our finding was corroborated in a separate study of low birth weight neonates who received only group O RBCs (e.g., group O neonates received ABO identical RBCs but group A, B, and AB neonates received ABO non-identical RBCs). A subgroup of neonates who received ABO non-identical transfusions had higher mortality (Z. Sohl, personal communication, April 30th, 2020). Similar adverse clinical outcomes have been reported in a number of studies where patients have received ABO non-identical RBCs and/or platelets. Together, these findings raise the concern that the longstanding policy of transfusing group O non-identical RBCs and platelets may increase the risk of harm for some patients. In Hamilton, Ontario hospitals, approximately 20% of transfused patients receive ABO non-identical RBCs every year because of inventory shortages, urgent requests, and specific phenotype requirements. The negative impact of this practice could have widespread national and international implications for transfusion policy. The ability to undertake critical exploratory analyses in transfusion medicine is enabled by large research and administrative data sets that include all Hamilton hospitals. The initial finding of potential harm with ABO non-identical RBCs is hypothesis-generating and requires confirmation through external datasets and translational studies to support a biological mechanism. If confirmed, this hypothesis can then be tested in a clinical trial.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 years of age 2. Diagnosis of MDS (Myelodysplastic syndrome ) without leukemia (IPSS-R classified or physician indicated either low-risk or intermediate-1) 3. Stable disease (as assessed by the patient's physician using MDS Stability Assessment Algorithm) 4. Blood group A, B, or AB 5. Requiring 2 RBC units at least every 6 weeks or less 6. Receiving transfusions in an outpatient setting Exclusion Criteria: 1. Unable to provide informed consent 2. Blood group O 3. Clinical requirement for special products because of reactions (e.g. washed or volume-reduced) |
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Hospital and Cancer Centre | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | CBS |
Canada,
Heal JM, Liesveld JL, Phillips GL, Blumberg N. What would Karl Landsteiner do? The ABO blood group and stem cell transplantation. Bone Marrow Transplant. 2005 Nov;36(9):747-55. doi: 10.1038/sj.bmt.1705101. — View Citation
Julmy F, Ammann RA, Taleghani BM, Fontana S, Hirt A, Leibundgut K. Transfusion efficacy of ABO major-mismatched platelets (PLTs) in children is inferior to that of ABO-identical PLTs. Transfusion. 2009 Jan;49(1):21-33. doi: 10.1111/j.1537-2995.2008.01914.x. Epub 2008 Sep 4. — View Citation
Lapierre V, Mahe C, Auperin A, Stambouli F, Oubouzar N, Tramalloni D, Benhamou E, Tiberghien P, Hartmann O. Platelet transfusion containing ABO-incompatible plasma and hepatic veno-occlusive disease after hematopoietic transplantation in young children. Transplantation. 2005 Aug 15;80(3):314-9. doi: 10.1097/01.tp.0000167758.63247.f4. — View Citation
Pai M, Cook R, Barty R, Eikelboom J, Lee KA, Heddle N. Exposure to ABO-nonidentical blood associated with increased in-hospital mortality in patients with group A blood. Transfusion. 2016 Mar;56(3):550-7. doi: 10.1111/trf.13376. Epub 2015 Oct 15. — View Citation
Refaai MA, Cahill C, Masel D, Schmidt AE, Heal JM, Kirkley SA, Blumberg N. Is It Time to Reconsider the Concepts of "Universal Donor" and "ABO Compatible" Transfusions? Anesth Analg. 2018 Jun;126(6):2135-2138. doi: 10.1213/ANE.0000000000002600. No abstract available. — View Citation
Zeller MP, Barty R, Aandahl A, Apelseth TO, Callum J, Dunbar NM, Elahie A, Garritsen H, Hancock H, Kutner JM, Manukian B, Mizuta S, Okuda M, Pagano MB, Poglod R, Rushford K, Selleng K, Sorensen CH, Sprogoe U, Staves J, Weiland T, Wendel S, Wood EM, van de Watering L, van Wordragen-Vlaswinkel M, Ziman A, Jan Zwaginga J, Murphy MF, Heddle NM, Yazer MH; Biomedical Excellence for Safer Transfusion (BEST) Collaborative. An international investigation into O red blood cell unit administration in hospitals: the GRoup O Utilization Patterns (GROUP) study. Transfusion. 2017 Oct;57(10):2329-2337. doi: 10.1111/trf.14255. Epub 2017 Aug 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the biomarkers of inflammation(C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1ß, TNF-a, IL-8, CD40 Ligand) | The biomarkers of inflammation tests that will be performed at different time points | Baseline | |
Primary | Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1ß, TNF-a, IL-8, CD40 Ligand) | The biomarkers of inflammation tests that will be performed at different time points | 1 hour after transfusion | |
Primary | Change in the biomarkers of inflammation from baseline (C-Reactive Protein, Circulating Immune Complexes, IL-6, IL-1ß, TNF-a, IL-8, CD40 Ligand) | The biomarkers of inflammation tests that will be performed at different time points | 12-24 hours after transfusion |
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