RecruitingNAINTERVENTIONAL

The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery

This study is exploring a technique called "retrograde autologous priming" (RAP) for patients having heart surgery needing a heart-lung machine. During surgery, the heart-lung machine needs to be filled with liquid before it’s connected to the patient. Normally, this is a water-based solution. RAP uses some of the patient's own blood to fill the machine instead. The main goal is to see if using RAP can reduce the number of blood transfusions patients need after surgery. This is important because blood transfusions carry some risks and there's a limited supply of blood. This current study is a "vanguard" trial, which means it's a small-scale trial to check if a much larger study on this topic would work well.

At a glance

Status

Recruiting

Phase

Sponsor

Population Health Research Institute

Enrolment target

4,500

Start

04 Dec 2024

Estimated completion

01 Nov 2026

Red Blood Cell Transfusion

What is this study about?

When you have heart surgery, especially if it involves a heart-lung machine, there's a chance you might need a blood transfusion. A blood transfusion is when you receive donated blood to replace blood you've lost. While transfusions can be life-saving, doctors usually try to avoid them if possible because they have some potential risks and there’s a limited supply of donated blood.

This study is looking at a technique called "retrograde autologous priming" (RAP). Think of the heart-lung machine like a pump that needs to be filled before it can start working. Traditionally, it's filled with a special water-based liquid. With RAP, instead of using this liquid, a small amount of the patient's own blood is used to fill (or 'prime') the machine. The idea is that using your own blood in this early step might help save your red blood cells during the surgery, potentially lowering the chance you'll need a transfusion afterwards.

This is a "vanguard trial," which means it's a practice run for a much bigger, more detailed study. Researchers want to find out if it's realistic for hospitals to regularly use this RAP technique. They will look at how well hospitals follow the study's plan and if the data they collect is useful for a future, larger study. If this smaller study goes well, it could lead to changes in how heart surgery is done, potentially benefiting many patients by reducing the need for blood transfusions.

Key takeaways

The study explores a technique using a patient's own blood for heart-lung machine preparation.
It aims to see if this can reduce the need for blood transfusions in heart surgery.
This is a "vanguard trial" – a practice run for a much bigger study.
It's about changes in hospital practice, not individual patient choices.
Data from patients undergoing heart surgery at participating hospitals will be included.
The ultimate goal is to improve safety and outcomes for future heart surgery patients.

Who may be eligible?

This study involves hospitals rather than individual patients. Hospitals can take part if they perform a good number of adult heart surgeries each year (more than 200). All the doctors, nurses, and specialists involved in heart surgery at that hospital must agree to participate and follow the study's guidelines for using either the RAP method or the standard method.

What this means for you as a patient is that if your hospital is taking part, and you are having heart surgery where a heart-lung machine is used, your information will be included in the study. You don't need to do anything extra. The study will look at information from all patients undergoing this type of surgery at participating hospitals, regardless of their gender and within a very broad age range (from 10 to 110 years old).

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 having a type of heart surgery that uses a heart-lung machine?
Is your hospital participating in this research study?
Are you generally between 10 and 110 years old?
Do you understand that your medical team will decide which priming method to use based on the study's schedule?

Answer every question to see your result.

What does participation involve?

As an individual patient, you wouldn't directly 'participate' in the traditional sense, as this study is primarily about how hospitals manage surgery rather than individual patient choices. If your hospital is involved in the study, and you are having heart surgery where a heart-lung machine is used, the data from your procedure would be included. You won't be asked to visit extra clinics, take different medications, or have additional assessments beyond your usual surgical care.

The study involves hospitals alternating between two methods of preparing the heart-lung machine (RAP or crystalloid priming) over several months. Your care team will decide which method to use for your surgery based on the study's schedule for that period. There will be no extra follow-up appointments specifically for this study; researchers will collect information on whether you needed a blood transfusion up to 72 hours after your surgery from your regular hospital notes. The total duration of this vanguard study is for a trial period at each participating hospital.

Potential risks and benefits

Because this study is about hospitals changing their standard practice rather than individual patients making choices, there are no specific direct risks to you as a patient beyond the usual risks associated with heart surgery. The techniques used in the study are standard for preparing the heart-lung machine. The potential benefit of this research is that if routine RAP is proven to be safe and effective in a larger trial, it could reduce the need for blood transfusions for many patients undergoing heart surgery in the future. This could lead to better recovery and fewer complications for patients. Even though individual patients aren't directly signing up for this study, your medical team will always discuss all aspects of your care with you, and you always have the right to discuss your treatments and make decisions about your care.

Locations (4)

St. Boniface Hospital
Verified postcode
Winnipeg, Canada· Recruiting
Hamilton General Hospital
Verified postcode
Hamilton, Canada· Recruiting
Montreal Heart Institute
Verified postcode
Montreal, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is the main goal of this study?

The main goal is to see if a technique called retrograde autologous priming (RAP) can reduce the number of blood transfusions needed after heart surgery, and if a larger study about this is possible.

What is "retrograde autologous priming" (RAP)?

It's a method where a small amount of a patient's own blood is used to fill the heart-lung machine before surgery, instead of a water-based liquid.

Will I have to do anything differently if my hospital is in the study?

No, as a patient, you won't need to do anything extra. The study involves your medical team choosing a particular method for your surgery based on the study's schedule.

Why is it important to reduce blood transfusions?

Reducing blood transfusions is important because there is a limited supply of donated blood, and transfusions can sometimes have their own risks or side effects.

What if my hospital isn't included?

If your hospital isn't included, your care will continue as normal. This is a research study to potentially improve future practices, not something that impacts current standard care everywhere.

How to find out more

TheRAPy Study Coordinator

therapy@phri.ca 9055212100 Official trial record

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