Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06840756

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (age 18 years or older)
  • Admission to a participating Intensive Care Unit (ICU)
  • Require red blood cell transfusion
Not Eligible

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

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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

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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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