Recruiting

RBC Transfusion

Sponsor:

Michelle Zeller

Code:

NCT06840756

Conditions

Red Blood Cell Transfusions

Sex Differences

Health Services

Critically Ill Intensive Care Unit Patients

Hematology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sex-mismatched red blood cell transfusions

Sex-matched red blood cell transfusions

Study Details

Brief 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.

Conditions

Red Blood Cell Transfusions

Sex Differences

Health Services

Critically Ill Intensive Care Unit Patients

Hematology

Study ID

NCT06840756

Start date

Sep 11, 2025

Status verified date

Mar, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

11082 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Sex-matched

Sex-matched red blood cell transfusion

active comparator: Sex-mismatched

Sex-mismatched red blood cell transfusion

Interventions

Sex-mismatched red blood cell transfusions

Sex-mismatched red blood cell transfusions

Sex-matched red blood cell transfusions

Sex-matched red blood cell transfusions

Primary outcome measure

  • 30 day mortality [ Time Frame: From randomization to 30 days post-randomization. ]

Central Contacts and Locations

Central contacts

Michelle Zeller, Doctor of Medicine

1-905-525-9140zeller@mcmaster.ca

Bambie Levoy-Jones, Honours Bachelor of Science

1-905-525-9140levoyjob@mcmaster.ca

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Andrew Shih, Doctor of Medicine

905-527-0271shiha@mcmaster.ca

Principal Investigator:

Andrew Shih, Doctor of Medicine

More Information

Sponsor

Michelle Zeller

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • transfusions
  • red blood cell transfusions
  • sex-matched
  • sex-mismatched
  • intensive care unit
  • ICU
  • cardiovascular
  • circulatory
  • hematology
  • mortality
  • blood donor characteristics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michelle Zeller on 2026-03-12.