Active not recruitingNAINTERVENTIONAL

Quantra® System With the QPlus® Cartridge in Double-lung Transplantation

This study is investigating if a new type of blood test, called the Quantra System with the QPlus Cartridge, can help doctors make better decisions about blood transfusions during double-lung transplant surgery. Transfusions, where patients receive donated blood, are very common during these complex operations. However, too many transfusions can sometimes cause problems for patients, increasing the risk of complications and even affecting survival. The Quantra test provides quick information about a patient's blood clotting ability. Researchers want to see if using this test to guide transfusions can reduce the overall amount of blood patients receive, ultimately making the surgery safer and improving recovery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hopital Foch

Enrolment target

128

Start

15 May 2023

Estimated completion

03 Oct 2025

Lung Diseases Transplant-Related Disorder

What is this study about?

When someone has a double-lung transplant, it's a major operation, and it's quite common for them to need blood transfusions. These transfusions involve getting donated blood, plasma (the liquid part of blood), or platelets (tiny cells that help blood clot) to help the body cope during surgery. While these transfusions are often necessary and life-saving, doctors are always looking for ways to give patients just the right amount, as receiving too much can sometimes lead to complications. These complications can include problems with how well the new lungs work after surgery, and in some cases, can even increase the risk of serious health issues.

That's where this study comes in. Doctors have found that certain special blood tests can help them understand how well a patient's blood is clotting during other types of complicated surgeries, like heart surgery or liver transplants. These tests, known as 'viscoelastic tests', give quick results about blood clotting. However, these specific tests haven't been widely used or studied before in lung transplants.

This study aims to find out if using a particular blood test from the Quantra System, called the QPlus Cartridge, can help doctors reduce the amount of blood given to patients during double-lung transplant surgery. The idea is that by getting quick and accurate information about a patient's clotting ability from this test, doctors can make more informed decisions about when and how much blood to give, potentially leading to fewer transfusions and better outcomes for patients. The study will compare patients who have transfusions guided by this new test with those who receive transfusions in the usual way.

Key takeaways

This study is for adult patients having a double-lung transplant.
It aims to see if a special blood test (Quantra) can reduce the need for blood transfusions during surgery.
Fewer transfusions might lead to better recovery.
Participation involves routine blood samples during surgery; no extra appointments.
You can choose to withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or over, who is about to have a double-lung transplant. You also need to be willing to participate and give your consent, and be covered by national health insurance.

There are certain reasons why someone might not be able to join the study. If you're under 18, or if you're having a different type of lung transplant (not a double-lung transplant), you wouldn't be eligible. Also, if you're already on a special life support machine called ECMO before your transplant, or if your surgery involves a heart-lung bypass machine, you won't be able to participate. Similarly, if you're having more than one organ transplanted at the same time, or if you are unable to make your own decisions (for example, if you are under guardianship) or simply do not wish to take part, then this study wouldn't be for you.

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 having a double-lung transplant?
Are you willing to participate and give your consent?
Are you not currently on a special life support (ECMO) before your transplant?
Is your surgery not involving a heart-lung bypass machine?
Are you not having other organs transplanted at the same time?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be part of either the group where doctors use the Quantra test to guide transfusions or the group where transfusions are given as usual. The main time of focus for this study is during your double-lung transplant surgery. The Quantra test involves taking small blood samples, similar to other blood tests you might have before or during surgery. These tests are done quickly to help guide decisions about blood transfusions. There are no additional visits or follow-up appointments specifically for this study beyond your standard transplant care. The total duration of your active involvement in the study will be limited to the time around your surgery, with information collected at that point.

Potential risks and benefits

A potential benefit of taking part in this study is that if the Quantra test proves effective, it might help reduce the amount of blood transfusions you receive during your double-lung transplant surgery, which could potentially lead to a smoother recovery and fewer complications. As with any medical procedure or study, there are potential risks, though in this case, the main intervention involves blood tests and information guiding existing care. The blood tests themselves carry the small, usual risks associated with any blood draw, such as minor bruising or discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care or your relationship with your healthcare team.

Locations (1)

Foch Hospital
Verified postcode
Suresnes, France

Common questions

What is a double-lung transplant?

It's a major surgery where both of your diseased lungs are replaced with healthy donor lungs.

What is a blood transfusion?

It's when you receive donated blood or blood components (like plasma or platelets) to replace what your body needs, often during a major surgery.

What is the Quantra test?

It's a special blood test that quickly checks how well your blood is clotting, helping doctors make decisions about transfusions.

Will taking part change my transplant surgery?

Your surgery will proceed as planned, but for some, decisions about blood transfusions will be guided by the results of the Quantra test during the operation.

Is the Quantra test safe?

The test itself involves a small blood sample and is generally safe, similar to other routine blood tests.