NCT04859218Completed
Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes?
Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 6 Apr 2021
- Start date
- Oct 2023
- Primary completion date
- Feb 2026
- Lead sponsor
- McMaster University
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT04859218
What you commit to
- Study type: Interventional
- Participants enrolled: 11
- From Oct 2023 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Unable to provide informed consent
- Blood group O
- Clinical requirement for special products because of reactions (e.g. washed or volume-reduced)
Who the study is looking for
- Age ≥ 18 years of age
- Diagnosis of MDS (Myelodysplastic syndrome ) without leukemia (IPSS-R classified or physician indicated either low-risk or intermediate-1)
- Stable disease (as assessed by the patient's physician using MDS Stability Assessment Algorithm)
- Blood group A, B, or AB
- Requiring 2 RBC units at least every 6 weeks or less
- Receiving transfusions in an outpatient setting
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juravinski Hospital and Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.