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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Michelle Zeller, Doctor of Medicine — McMaster University
• Study coordinator: Michelle Zeller, Doctor of Medicine
• Email: zeller@mcmaster.ca
• Phone: 1-905-525-9140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Sex Differences in BDNF Response to a Maximal Exercise Test

  This study tests whether men and women have different levels of BDNF in the blood after a maximal exercise test.

  Recruiting McMaster University · Hamilton, Ontario · NCT07912307

• Iron status at ICU discharge in adults with anemia after critical illness

  We are testing whether iron deficiency is common at ICU discharge and whether it relates to how well patients recover after leaving the ICU.

  Recruiting Università degli Studi di Ferrara · Brussels and 3 other locations · NCT07781540

• How MOR Activation Affects Stress and Social Behavior, and How Childhood Unpredictability Modulates This in Men and Women

  This study tests whether activating the mu opioid receptor with morphine changes stress responses and social behavior, and whether sex and early life unpredictability alter those effects.

  Recruiting Psychiatric University Hospital, Zurich · Zurich · NCT07778511

• Hepatic Vein Filling Fraction vs TAPSE to Check Right Heart Function in Mechanically Ventilated ICU Patients

  We’re testing if the hepatic vein systolic filling fraction can reliably show how well the right side of the heart is pumping in adults on breathing machines in the ICU.

  Recruiting Menoufia University · Alexandria, Shebin El-Kom · NCT07732114

• Sex differences in postoperative delirium and whether family visits help

  This study looks to see if a patient’s sex changes the risk of delirium after non-cardiac surgery and whether family visits can help prevent it, especially in adults 65 and older.

  Recruiting University of Zurich · Zurich · NCT07502391

• Syai Tag continuous glucose monitoring for ICU patients

  This will try the Syai Tag continuous glucose monitor in adult ICU patients with arterial lines to see if its readings match standard arterial blood glucose tests.

  Recruiting University Medical Centre Maribor · Maribor · NCT07448805

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.