RecruitingPhase 4NCT06840756

Effects of Donor-recipient Sex-matched Blood Transfusion on Patient Outcomes

Effects of Donor-recipient Sex-matched Versus Sex-mismatched Red Blood Cell Transfusion on Outcomes in Critically Ill Adult Patients


Sponsor

Michelle Zeller

Enrollment

11,082 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Adults (age ≥18);
  • Admission to a participating ICU;
  • Requiring RBC transfusion.

Exclusion Criteria4

  • Requirement for a specialized RBC product or unit not readily available in inventory (e.g., rare blood type, washed RBCs, complex RBC antibodies, etc.);
  • Massively bleeding patient (i.e., ≥4 units of blood ordered at one time, or Massive Hemorrhage Protocol initiated, or an urgent blood request made);
  • Sex unknown or sex other than male or female (i.e. intersex);
  • Do not have a valid Ontario Health Insurance Plan (OHIP) health card number.

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Interventions

BIOLOGICALSex-mismatched red blood cell transfusions

Sex-mismatched red blood cell transfusions

BIOLOGICALSex-matched red blood cell transfusions

Sex-matched red blood cell transfusions


Locations(8)

Hamilton General Hospital

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06840756


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