Donor-recipient sex matching for red blood cell transfusions in adult ICU patients

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

We will test whether giving adult ICU patients red blood cell transfusions from donors of the same sex improves survival compared with transfusions from donors of the opposite sex.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11082 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: McMaster University (Academic / other)
• Locations: 8 sites (Hamilton, Ontario and 7 other locations)
• Trial ID: NCT06840756 on ClinicalTrials.gov

What this trial studies

This is a multicenter, pragmatic, phase 4 randomized controlled trial enrolling adults admitted to participating intensive care units who require a red blood cell transfusion. Participants are randomized to receive either sex-matched or sex-mismatched donor red blood cell units, with common exclusions such as massive hemorrhage, need for specialized/rare RBC products, or unknown/non-binary sex. The trial builds on prior observational analyses, a pilot RCT, and biological data suggesting a possible benefit from sex-matching, and is powered to compare mortality and clinical outcomes between groups. The protocol is being conducted across several Ontario teaching hospitals with CIHR-supported oversight.

Who should consider this trial

Good fit: Adults (age ≥18) admitted to a participating ICU who require a red blood cell transfusion and have a valid Ontario health card are eligible to join.

Not a fit: Patients who are massively bleeding, require specialized or rare blood products, or whose sex is unknown or is not male/female are not eligible and would not receive potential benefit from this matching strategy.

Why it matters

Potential benefit: If successful, sex-matching donor and recipient red blood cell transfusions could reduce deaths and transfusion-related complications in ICU patients who need transfusions.

How similar studies have performed: Observational studies and a large exploratory analysis have suggested a signal of benefit and emerging biological plausibility, but results have been mixed and a definitive large randomized trial has not yet confirmed benefit.

Eligibility criteria

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.

Where this trial is running

Hamilton, Ontario and 7 other locations

• Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
• Kingston Health Sciences Centre — Kingston, Ontario, Canada (Not_yet_recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
• Lakeridge Health Oshawa — Oshawa, Ontario, Canada (Not_yet_recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Not_yet_recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
• Mount Sinai Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Michelle Zeller, Doctor of Medicine — McMaster University
• Study coordinator: Michelle Zeller, Doctor of Medicine

Conditions Red Blood Cell Transfusions; Sex Differences; Health Services; Critically Ill Intensive Care Unit Patients; Hematology; Cardiovascular; transfusions; red blood cell transfusions