RecruitingNAINTERVENTIONAL

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

This research, called TRICS-IV, is an international study involving many hospitals. It's designed for patients aged 18 to 65 who are having open-heart surgery using a heart-lung machine. The study aims to compare two different strategies for giving blood transfusions during and after surgery. One strategy is more 'restrictive', meaning transfusions are given only when absolutely necessary. The other is more 'liberal', meaning transfusions might be given more readily. Researchers want to find out which approach leads to better outcomes for patients, helping us understand the best way to manage blood transfusions during these important operations. This is a "randomised controlled trial," meaning participants will be assigned to one strategy by chance.

At a glance

Status

Recruiting

Phase

Sponsor

Unity Health Toronto

Enrolment target

1,440

Start

01 Nov 2021

Estimated completion

01 Jun 2026

Disorder Heart Postoperative Cardiac Surgery

What is this study about?

This study, known as TRICS-IV, is looking into the best way to give blood transfusions to younger patients having heart surgery. When you have heart surgery, especially with a heart-lung machine, you might need a blood transfusion. There are currently two main approaches doctors use: a 'restrictive' approach, where transfusions are given only when a patient's blood levels drop significantly, and a 'liberal' approach, where transfusions might be given a bit sooner or more often.

The main aim of this study is to compare these two common strategies side-by-side. Researchers want to see if one approach leads to better results for patients. This includes looking at things like recovery, complications, and overall well-being after surgery. By understanding which strategy is more beneficial, doctors can improve the care and safety for people undergoing serious heart operations.

The study involves many hospitals around the world and is designed to be very thorough. Patients who are part of the study will be randomly assigned to either the restrictive or liberal transfusion group, similar to flipping a coin. This helps ensure the comparison between the two strategies is fair and unbiased. The findings from TRICS-IV will help guide future medical practice and improve decisions about blood transfusions for heart surgery patients.

Key takeaways

This study compares two common strategies for blood transfusions during heart surgery.
It aims to find the safest and most effective way to give blood to patients.
Participants will be between 18 and 65 years old and having open-heart surgery.
You will be randomly assigned to one of the two transfusion strategies.
The study helps improve future care for heart surgery patients.

Who may be eligible?

This study is looking for volunteers between the ages of 18 and 65. You would need to be planning to have heart surgery where a heart-lung machine will be used. This is a common part of many open-heart operations.

To be considered for the study, your doctor would also need to assess your risk level for the surgery. They use a standard scoring system, and participants would typically have a score of 6 or more, which suggests a moderate to higher-risk surgery.

There are some reasons why you couldn't join. For example, if you don't want to participate, or if you can't or won't accept blood transfusions for any reason. If you're pregnant or breastfeeding, or if you're having a heart transplant or only having a device called a ventricular assist device fitted, you wouldn't be able to take part. Also, if you’ve already donated your own blood for use in your upcoming surgery, you wouldn’t be eligible.

Quick self-check

Are you between 18 and 65 years old?
Are you scheduled for heart surgery that uses a heart-lung machine?
Are you willing and able to receive blood transfusions?
Are you not pregnant or breastfeeding?
Are you comfortable with the idea of being randomly assigned to a transfusion strategy?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first be asked to give your 'informed consent', which means you understand the study and agree to participate. You'll then be randomly assigned to one of two groups: either a 'restrictive' blood transfusion strategy or a 'liberal' strategy during your heart surgery and recovery. This assignment is by chance, like drawing lots.

Your medical team will follow the specific transfusion strategy for your group. This doesn't mean you'll be given blood unnecessarily or deprived of it if you need it; it just guides when a transfusion is considered. All aspects of your surgery and recovery, apart from this transfusion strategy, will be managed as normal by your doctors.

Your doctors will carefully monitor your health throughout your hospital stay, just as they would for any patient undergoing heart surgery. They will collect information about your recovery and progress. There won't be any extra visits or follow-up appointments specifically for the study beyond your usual post-surgery care. The total duration of your participation will cover your hospital stay and recovery period.

Potential risks and benefits

Taking part in this study might offer a benefit by helping doctors learn more about the best way to manage blood transfusions during heart surgery, which could improve care for everyone in the future. While there are no direct personal benefits guaranteed, you would receive the same high standard of medical care as any patient undergoing similar surgery. The risks associated with the study are generally those inherent in any heart surgery and blood transfusion. You might receive blood transfusions slightly more or less frequently depending on which group you're in, but doctors will always ensure your safety and well-being. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (54)

Maine Medical Center
Portland, United States· Recruiting
The Cooper Health System
Camden, United States· Recruiting
Columbia University
New York, United States· Not yet recruiting
Thomas Jefferson University
Philadelphia, United States· Active not recruiting
Royal Adelaide Hospital
Adelaide, Australia· Recruiting
Royal Prince Alfred hospital
Camperdown, Australia· Recruiting
Prince of Wales Hospital
Randwick, Australia· Recruiting
Westmead Hospital
Westmead, Australia· Recruiting
Gold Coast University Hospital
Southport, Australia· Recruiting
Flinders Medical Centre
Bedford Park, Australia· Recruiting
Monash Health
Clayton, Australia· Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Australia· Recruiting

+42 more sites — see the official record for the full list.

Common questions

What is a 'restrictive' or 'liberal' transfusion strategy?

A restrictive strategy means doctors wait until your blood iron levels are lower before giving a transfusion. A liberal strategy means a transfusion might be given at slightly higher blood iron levels.

Will I definitely receive a blood transfusion if I join?

Not necessarily. Whether you receive one or not will depend on your individual medical needs during and after surgery, guided by the transfusion strategy you're assigned to.

Will I know which transfusion strategy I am getting?

Yes, this is an 'open-label' study, meaning both you and your medical team will typically know which transfusion strategy you are assigned to.

Will participating in this study affect my usual post-surgery care?

No, your medical care will be managed by your doctors as usual. The study only focuses on guiding decisions about blood transfusions.

What if I change my mind after joining the study?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care or your relationship with your doctors.

How to find out more

David Mazer, MD

David.Mazer@unityhealth.to 416-864-5825 Official trial record

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