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Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06840756

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (age 18 or older)
  • Admission to a participating intensive care unit (ICU)
  • Requiring red blood cell (RBC) transfusion
Not Eligible

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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