Actively Recruiting
Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
Led by Michelle Zeller · Updated on 2026-03-12
11082
Participants Needed
8
Research Sites
185 weeks
Total Duration
On this page
Sponsors
M
Michelle Zeller
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Red blood cell (RBC) transfusions are selected based upon matching donor and recipient blood group: donor and recipient sex are not considered when selecting blood for transfusion. Hence, transfused patients can currently receive sex-matched and/or unmatched RBCs when transfusions are given. Sex-matched stem cell transplants, and some solid organ transplants, have shown that sex-matching donor to recipient improves patient outcomes. Recent exploratory studies have also suggested that patient outcomes could be improved by sex-matching for RBC transfusion. There is emerging evidence of underlying biologic mechanism(s) to support these observations. This study is designed as a randomized controlled trial and will explore the impact on patients who receive RBC transfusions from donors of the same sex ("sex-matched") compared with donors of the opposite sex ("sex-mismatched"). The trial will study adult patients admitted to the Intensive Care Unit who require an RBC transfusion. Patients will be assigned (through a process called randomization) to receive sex-matched RBCs or sex-mismatched RBCs to determine if there is a difference in mortality between those receiving matched versus mismatched RBCs. The results of this trial could have direct implications on resources, blood inventory, and RBC transfusion ordering practices.
CONDITIONS
Official Title
Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (age 18 years or older)
- Admission to a participating Intensive Care Unit (ICU)
- Require red blood cell transfusion
You will not qualify if you...
- Need for specialized red blood cell products not readily available (e.g., rare blood type, washed RBCs, complex antibodies)
- Massive bleeding requiring 4 or more blood units at once, initiation of Massive Hemorrhage Protocol, or urgent blood request
- Sex unknown or other than male or female (intersex)
- No valid Ontario Health Insurance Plan (OHIP) health card number
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
2
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Not Yet Recruiting
3
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Not Yet Recruiting
4
Lakeridge Health Oshawa
Oshawa, Ontario, Canada, L1G 8A2
Not Yet Recruiting
5
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 1J8
Not Yet Recruiting
6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
7
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Not Yet Recruiting
8
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
Research Team
M
Michelle Zeller, Doctor of Medicine
CONTACT
B
Bambie Levoy-Jones, Honours Bachelor of Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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