RecruitingOBSERVATIONAL

Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant

This study looks at a medical procedure called Abdominal Normothermic Regional Perfusion (A-NRP) that's used for organ donation after someone has died due to their heart stopping. The main goal is to check really carefully that during this A-NRP procedure, there is absolutely no blood flow or activity in the donor's brain. Doctors will use special tools to continuously monitor the brain. This is important to confirm the safety and proper use of this technique when preparing organs for transplant, reassuring everyone involved that the donor's brain has permanently stopped working. The study aims to provide strong evidence to support using A-NRP in routine medical care.

At a glance

Status

Recruiting

Sponsor

Western University, Canada

Enrolment target

Start

02 Apr 2024

Estimated completion

01 Dec 2027

Organ Transplant

What is this study about?

This research is looking at a specific way organs are prepared for transplant. Sometimes, when a person has sadly died because their heart and breathing have stopped permanently, they can still be an organ donor. This is called 'donation by circulatory criteria' (DCC).

One part of preparing these organs for transplant can involve a procedure called Abdominal Normothermic Regional Perfusion (A-NRP). This is a technique that helps keep the donated organs in good condition before they are moved for transplant. The main question this study wants to answer is whether, during this A-NRP procedure, there is ever any return of blood flow or activity to the donor's brain. It’s absolutely crucial to confirm that irreversible brain death has occurred and is maintained.

To do this, doctors will use special monitoring equipment that continuously checks the donor's brain as the A-NRP procedure happens. This will help them see if there's any sign of blood flow or electrical activity in the brain. The study wants to show clear evidence that the brain remains without activity and blood flow throughout the process, ensuring the ethical and safe use of this technique for organ donation.

Key takeaways

The study checks brain activity during organ donation after heart stop.
It aims to confirm no blood flow or activity in the brain during A-NRP.
Special monitoring tools are used during the standard organ donation process.
This research helps ensure the safety and ethical use of organ donation techniques.
Families can decide if their loved one takes part in the study, it's voluntary.

Who may be eligible?

This study is looking for potential organ donors who are 18 years old or older, up to 75 years of age. These are individuals who have sadly died because their heart stopped permanently, and their families have agreed to organ donation. They might be donating organs like the liver, kidneys, pancreas, or lungs.

However, there are also some reasons why someone might not be able to join the study. If a person is under 18 years old, they cannot take part. Also, if a donor had medical assistance in dying, or if they were able to give their own consent at the time of donation, they would not be eligible for this specific study.

Finally, if there are injuries that make it impossible to use the special brain monitoring equipment, then that person would also not be able to be included in this research.

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.

Is the potential donor 18 years old or older, up to 75?
Has the family consented to organ donation after the heart has stopped?
Are there no injuries that would prevent placing brain monitoring equipment?
Did the potential donor not receive medical assistance in dying?

Answer every question to see your result.

What does participation involve?

This study is observational, so it won't involve any new treatments or procedures beyond the standard organ donation process. If an eligible donor is identified and their family has consented to organ donation, special brain monitoring equipment will be used during the A-NRP procedure. This involves placing sensors to measure brain blood flow and electrical activity.

Doctors who are not part of the transplant team will watch these signals carefully in real-time. This monitoring will happen during the standard time the A-NRP procedure is used, and there won't be any additional visits or follow-up appointments related specifically to the study. The total duration of study involvement would be limited to the time of the A-NRP procedure.

Potential risks and benefits

The potential benefits of this study are for future organ donation practices. By confirming the safety and effectiveness of the A-NRP procedure in maintaining permanent lack of brain activity, it can help more people receive life-saving organ transplants. For the individual donor, there are no direct benefits as they have already passed away. The risks for the donor relate mainly to the placement of the monitoring equipment. However, these are standard, non-invasive procedures. Families should be assured that participation is entirely voluntary and they have the right to withdraw consent for their loved one's involvement in the study at any time without affecting the organ donation process.

Locations (2)

London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Toronto Western Hospital
Verified postcode
Toronto, Canada· Not yet recruiting

Common questions

What is A-NRP?

A-NRP is a special medical procedure used to help preserve organs for transplant after someone has died from their heart stopping.

Why is this study being done?

The study aims to confirm that there is no brain activity or blood flow to the brain during the A-NRP procedure, making sure it’s safe and ethical for organ donation.

Will this affect the organ donation process?

No, the study carefully monitors already established procedures and will not change the way organ donation happens. It’s an extra check for safety.

Who is monitoring the brain activity?

Specialist teams, independent of the transplant team, will be monitoring the brain activity in real-time.

Can a family decide not to participate?

Yes, participation is completely voluntary, and families can choose not to have their loved one included in the study without affecting organ donation.

How to find out more

Crystal Engelage, PhD

crystal.engelage@lhsc.on.ca 519-685-8500 Official trial record

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