RecruitingPHASE4INTERVENTIONAL

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

This research is investigating whether matching the sex of a blood donor to the patient receiving blood transfusions in intensive care can lead to better health outcomes. Currently, blood is matched by blood type, not sex. However, similar studies with stem cell and organ transplants have hinted that sex-matching could be important. This study will involve adult patients in intensive care who need a red blood cell transfusion. Some will receive sex-matched blood, while others will receive sex-mismatched blood. By carefully comparing their recovery, especially survival rates, the researchers hope to learn if this simple change in how we choose blood could make a significant difference to patients' health. The findings could potentially improve how blood transfusions are given in the future.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Michelle Zeller

Enrolment target

11,082

Start

11 Sep 2025

Estimated completion

31 Mar 2029

Red Blood Cell Transfusions Sex Differences Health Services Critically Ill Intensive Care Unit Patients Hematology Cardiovascular

What is this study about?

Imagine you're in the intensive care unit (ICU) and need a blood transfusion. Right now, doctors make sure you get the right blood type, but they don't usually consider if the donor is male or female. This study is asking an important question: does it matter?

Researchers are looking into whether giving blood from a donor of the same biological sex (for example, a woman receiving blood from a female donor) could be better for patients than receiving blood from a donor of a different sex. This idea comes from other areas of medicine, like stem cell and organ transplants, where matching the donor's sex has sometimes shown to improve how well the patient recovers. There are also new scientific clues suggesting why this might be the case for blood transfusions.

This study aims to answer this question by carefully comparing two groups of critically ill adult patients in the ICU who need blood transfusions. One group will receive blood from a sex-matched donor, and the other will receive blood from a sex-unmatched donor. By doing this comparison, doctors hope to understand if a simple change in how blood is selected could lead to better chances of survival for patients. The results could help improve blood transfusion practices for everyone.

Key takeaways

This study explores a new way to pick blood for transfusions.
It investigates if matching donor and patient sex improves patient recovery.
Specifically looks at critically ill adults needing transfusions in intensive care.
Aims to understand if this could lead to better survival rates.
Could change future blood transfusion practices if successful.

Who may be eligible?

This study is looking for adult patients who are 18 years old or older and have been admitted to an Intensive Care Unit (ICU) that is part of this study. You would also need to be requiring a red blood cell transfusion during your time in the ICU to be considered.

However, there are certain situations where you wouldn't be able to join. For example, if you need a very special type of blood product that isn't commonly available, or if you're in a situation where you need a large amount of blood very quickly due to severe bleeding, this study might not be right for you.

Also, if your biological sex isn't clearly male or female, or is unknown, you wouldn't be included. For practical reasons, you'd also need to have a valid Ontario Health Insurance Plan (OHIP) card number.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently an admitted patient in an Intensive Care Unit (ICU)?
Do you require a red blood cell transfusion?
Do you have a valid Ontario Health Insurance Plan (OHIP) card number?
Are you NOT in a situation where you need a very large amount of blood rapidly (e.g., severe bleeding)?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your participation in this study would be quite straightforward and wouldn't involve any extra appointments or medications beyond what you would normally receive as part of your ICU care. The main difference is that when you need a red blood cell transfusion, the staff would check if the donor's sex matches yours or not.

This is done by a process called "randomization," which is like flipping a coin to decide which type of blood you receive. Your medical team will then closely monitor your health and recovery, just as they normally would in the ICU. The study will track your health outcomes, particularly survival, for approximately 30 to 90 days after you receive the blood transfusion. The total duration of your involvement would be based on how long you are in the hospital and for a period afterwards as researchers collect information about your recovery.

Potential risks and benefits

The potential benefit of taking part in this study is contributing valuable information that could improve blood transfusions for future patients. There's a chance, based on earlier findings, that receiving sex-matched blood could lead to a better recovery for you, but this is what the study aims to find out. The risks are generally low, as you would be receiving a standard, safe blood transfusion, regardless of whether it's sex-matched or mismatched. However, as with any medical treatment, there are always potential, although rare, complications. You have the full right to stop participating in the study at any time without it affecting your medical care.

Locations (8)

Hamilton General Hospital
Verified postcode
Hamilton, Canada· Recruiting
Kingston Health Sciences Centre
Verified postcode
Kingston, Canada· Not yet recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Not yet recruiting
Lakeridge Health Oshawa
Verified postcode
Oshawa, Canada· Not yet recruiting
The Ottawa Hospital
Verified postcode
Ottawa, Canada· Not yet recruiting
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Not yet recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
Toronto General Hospital
Verified postcode
Toronto, Canada· Not yet recruiting

Common questions

What is a 'red blood cell transfusion'?

It's a common medical procedure where you receive healthy red blood cells through a drip into your vein to replace blood you've lost or to help your body if it's not making enough.

Why don't doctors usually match a blood donor's sex to the patient?

Currently, the most important match for blood transfusions is blood type (like A, B, AB, or O) to ensure safety. Sex matching hasn't been a standard practice because we didn't have enough clear evidence that it made a difference, but this study aims to explore that.

Will I know if I'm getting sex-matched or sex-mismatched blood?

Because this is a study to fairly compare the two, you might not be told which type you received immediately. This helps ensure the results are unbiased. Your medical team will focus on providing the best care for you.

Will my care be different if I join the study?

No, your overall medical care in the Intensive Care Unit will remain exactly the same. The only difference is how the particular unit of blood for your transfusion is chosen for the study purpose.

What happens if this study shows that matching sex is better?

If the study finds clear benefits, it could change how blood transfusions are given in the future, making them even safer and more effective for patients, potentially leading to new guidelines.

How to find out more

Michelle Zeller, Doctor of Medicine

zeller@mcmaster.ca 1-905-525-9140 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.