Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
NCT04859218

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

Led by McMaster University · Updated on 2024-10-17

30

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

M

McMaster University

Lead Sponsor

C

CBS

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of Myelodysplastic Syndrome without leukemia (low-risk or intermediate-1)
  • Stable disease as assessed by physician
  • Blood group A, B, or AB
  • Requires 2 red blood cell units at least every 6 weeks or less
  • Receiving transfusions in an outpatient setting
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Blood group O
  • Clinical need for special blood products due to reactions (e.g., washed or volume-reduced)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada, L8V-1C3

Actively Recruiting

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Research Team

D

Donald Arnold

CONTACT

N

Nancy Heddle

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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