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Blood transfusion breakdown: could Sex-Matching save lives in the ICU?

NCT ID NCT06840756

Knowledge-focused Sponsor: Michelle Zeller Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving critically ill ICU patients red blood cells from a donor of the same sex (sex-matched) versus the opposite sex (sex-mismatched) affects their chance of survival. Over 11,000 adults in ICUs who need a transfusion will be randomly assigned to receive either sex-matched or sex-mismatched blood. The goal is to see if a simple change in blood bank practice could improve outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
red blood cell transfusion (sex-matched or sex-mismatched)
What this could lead to
If it works, this could lead to a simple change in transfusion practice that improves survival for critically ill patients.
What could go wrong
This is a large trial, but the benefit of sex-matching is uncertain based on early studies. The results may show no difference or be difficult to implement broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 11,082 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hematologic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular Critically ill intensive care unit patients Health services Hematology Red blood cell transfusions Sex differences

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hamilton General Hospital

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Kingston Health Sciences Centre

    NOT_YET_RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Lakeridge Health Oshawa

    NOT_YET_RECRUITING

    Oshawa, Ontario, L1G 8A2, Canada

  • London Health Sciences Centre

    NOT_YET_RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Mount Sinai Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1X5, Canada

  • Sunnybrook Health Sciences Centre

    NOT_YET_RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • The Ottawa Hospital

    NOT_YET_RECRUITING

    Ottawa, Ontario, K1Y 1J8, Canada

  • Toronto General Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

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