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Clinical Trials in Canada / NCT06840756
Recruiting Phase 4

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

NCT06840756 · tracked via the Priya Life Science Canada tracker
Sponsor
Michelle Zeller
Phase
Phase 4
Started
2025-09-11
Last updated
2026-03-12

Condition(s) studied

Red Blood Cell TransfusionsSex DifferencesHealth ServicesCritically Ill Intensive Care Unit PatientsHematologyCardiovascular

Investigational drug(s) / intervention(s)

Sex-mismatched red blood cell transfusionsSex-matched red blood cell transfusions

Sex-mismatched red blood cell transfusions: Sex-mismatched red blood cell transfusions

Sex-matched red blood cell transfusions: Sex-matched red blood cell transfusions

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults (age ≥18); * Admission to a participating ICU; * Requiring RBC transfusion. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Hamilton General Hospital Hamilton Ontario Recruiting
Kingston Health Sciences Centre Kingston Ontario Not Yet Recruiting
London Health Sciences Centre London Ontario Not Yet Recruiting
Lakeridge Health Oshawa Oshawa Ontario Not Yet Recruiting
The Ottawa Hospital Ottawa Ontario Not Yet Recruiting
Sunnybrook Health Sciences Centre Toronto Ontario Not Yet Recruiting
Mount Sinai Hospital Toronto Ontario Not Yet Recruiting
Toronto General Hospital Toronto Ontario Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06840756 on ClinicalTrials.gov ↗ ← All trials in Canada