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Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes?

Study acronym: UD
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Jul 2025 to Feb 16, 2026 Study completion date changed from estimate of Dec 2025 to Sep 10, 2026 · Trial completed · Final enrollment: 11 participants (planned 30) · 4 more Show 7 more changesShow less
    • Study completion date changed from estimate of Dec 2025 to Sep 10, 2026
    • Trial completed
    • Final enrollment: 11 participants (planned 30)
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 19 words
    • Site details revised
    • Publications: details revised at 6 of 6 entries
  2. Primary completion date: Jul 2024 to Jul 2025 Completion date: Dec 2024 to Dec 2025 · Start date changed from estimate of Nov 2023 to Oct 17, 2023v7 Show 2 more changesShow less
    • Completion date: Dec 2024 to Dec 2025
    • Start date changed from estimate of Nov 2023 to Oct 17, 2023
  3. Primary completion date: Oct 2023 to Jul 2024 Start date: Feb 2023 to Nov 2023 · Completion date: Dec 2023 to Dec 2024v6 Show 2 more changesShow less
    • Start date: Feb 2023 to Nov 2023
    • Completion date: Dec 2023 to Dec 2024
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 1, 2022 to Feb 2023 · Primary completion date: Sep 1, 2023 to Oct 2023 · Completion date: Sep 1, 2023 to Dec 2023v5 Show 3 more changesShow less
    • Start date: Oct 1, 2022 to Feb 2023
    • Primary completion date: Sep 1, 2023 to Oct 2023
    • Completion date: Sep 1, 2023 to Dec 2023
  5. Start date: Jul 1, 2022 to Oct 1, 2022v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 1, 2022 to Jul 1, 2022v3
  2. Start date: Aug 1, 2021 to Mar 1, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04859218
Lead Sponsor McMaster University
Collaborators: CBS
Conditions Myelodysplastic Syndrome
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov