Actively Recruiting
Impact of Donor and Recipient Sex Matching in Red Blood Cell Transfusions on Outcomes for Critically Ill Adults in ICU
Led by Michelle Zeller · Updated on 2026-03-12
11082
Participants Needed
8
Research Sites
12 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
Researchers are investigating whether matching the sex of blood donors and recipients for red blood cell RBC transfusions can improve patient outcomes in critically ill adults admitted to intensive care units ICUs. This randomized controlled trial will compare mortality rates between patients receiving sex-matched RBC transfusions and those receiving sex-mismatched RBC transfusions. Previous studies and biological evidence suggest that sex-matched transplants may benefit patients, but current transfusion practices do not consider donor-recipient sex. The study will enroll adult ICU patients requiring RBC transfusions and randomly assign them to receive either sex-matched or sex-mismatched blood. The trial will take place across multiple Canadian sites and include two groups one receiving sex-matched RBC transfusions and the other sex-mismatched transfusions. The primary outcome is 30-day mortality, with secondary outcomes including in-hospital mortality, 90-day mortality, time to death, changes in hemoglobin and kidney function, ICU and hospital stay length, transfusion reactions, and cost-effectiveness. Participants will be monitored from the time of randomization through 30 to 90 days post-transfusion, with assessments including blood tests to measure hemoglobin and creatinine levels, tracking of transfusion products used, and recording of adverse reactions. Researchers will collect data on patient outcomes, transfusion details, and healthcare resource use. The study aims to provide evidence on whether sex-matched transfusions improve survival and inform future blood transfusion practices and blood inventory management.
CONDITIONS
Brief 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 or older)
- Admission to a participating intensive care unit (ICU)
- Requiring red blood cell (RBC) transfusion
You will not qualify if you...
- Need for a specialized RBC product or unit not readily available (e.g., rare blood type, washed RBCs, complex antibodies)
- Massively bleeding patient (4 or more units ordered at once, massive hemorrhage protocol, or urgent blood request)
- Sex unknown or other than male or female (e.g., intersex)
- No valid Ontario Health Insurance Plan (OHIP) health card number
Research Team
M
Michelle Zeller, Doctor of Medicine
B
Bambie Levoy-Jones, Honours Bachelor of Science
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