RecruitingNAINTERVENTIONAL

Assessment of a Quantra-guided Transfusion Algorithm in Liver Transplantation

This study is investigating a new approach to managing bleeding during liver transplant surgery. Liver transplants can involve a lot of bleeding, and it's often tricky for doctors to know exactly when and how much blood to give. This research uses a quick, new device called Quantra that helps doctors understand blood clotting better. The study will compare whether using this Quantra-guided approach reduces the need for blood transfusions and bleeding during the operation, compared to the standard methods currently used. The goal is to make liver transplant surgery safer and improve outcomes for patients by guiding decisions about when to give blood products more accurately.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

Start

08 Mar 2025

Estimated completion

01 Mar 2027

Liver Transplantation

What is this study about?

When someone needs a liver transplant, it’s a big operation, and one of the main challenges for doctors is managing any bleeding that might occur. Patients who need a liver transplant often have problems with their blood clotting, which can make things even more complicated. Current ways of measuring how well blood clots can sometimes be slow and don't always give a full picture of what's happening during surgery.

This study is looking at a new device called Quantra. Think of it like a quick test that gives doctors a much clearer and faster idea of how a patient's blood is clotting during the operation. This information can help them decide more precisely if and when to give blood transfusions or other treatments. The main aim is to see if using this new Quantra-guided information helps to reduce the amount of bleeding and the need for blood transfusions during the transplant.

By helping doctors make more accurate decisions about blood transfusions, this study hopes to make liver transplant surgery even safer. It could potentially mean less bleeding for patients and fewer transfusions of blood products, which can have its own benefits. The study will compare how well this new method works against the standard way doctors currently manage transfusions.

Key takeaways

This study compares a new device (Quantra) for guiding blood transfusions during liver transplants.
The aim is to reduce bleeding and the need for transfusions.
You must be an adult having a liver transplant for severe liver disease to participate.
It's about finding better ways to manage blood clotting during tricky operations.
Participation involves being randomly assigned to standard or Quantra-guided care.

Who may be eligible?

To join this study, you must be at least 18 years old and be having a liver transplant because of severe liver disease. You also need to be part of a social security scheme (like the NHS) and be able to give your informed consent, meaning you understand the study and agree to take part, either yourself or through a trusted family member if you can't.

However, there are reasons why you wouldn't be able to join. For example, if you're having more than one organ transplanted at the same time, or if you have a known blood clotting disorder that you were born with, like haemophilia. Pregnant or breastfeeding women also can't take part, and neither can people who are already in another research study looking at reducing bleeding or transfusions during surgery.

Also, if you are legally unable to make your own decisions (for example, if you are under guardianship), you wouldn't be able to participate in this study.

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 at least 18 years old?
Are you having a liver transplant for liver disease?
Do you have a clear understanding of the study and agree to take part?
Are you not currently involved in another study about reducing bleeding in surgery?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not fully provided in the summary. However, based on the information, if you join this study, your liver transplant surgery would proceed as planned. The main difference would be how your medical team manages any transfusions that might be needed. Instead of solely relying on the usual tests, doctors would also use information from the Quantra device to guide their decisions. You would be randomly assigned to either receive care guided by the Quantra device or by the standard method. There would likely be follow-up to monitor your recovery. The total duration of your participation would cover your surgery and recovery period, but the specific length isn't stated.

Potential risks and benefits

Potential benefits of taking part include contributing to medical knowledge that could improve care for future liver transplant patients, and potentially, if you are in the Quantra-guided group, receiving a more precise approach to transfusion management during your surgery. All medical procedures carry risks; in this study, the risks would be those usually associated with liver transplant surgery itself. The study procedure involves different ways of guiding transfusions, but it's important to know that doctors will always act in your best interest. You have the right to withdraw from the study at any time without any impact on your medical care.

Locations (1)

Toulouse University Hospital
Verified postcode
Toulouse, France· Recruiting

Common questions

What is a 'transfusion algorithm'?

It's simply a set of guidelines or steps that doctors follow to decide when and how much blood or blood products to give during surgery.

What is Quantra?

Quantra is a quick testing device used during surgery to understand how well a patient's blood is clotting, helping doctors make faster decisions about transfusions.

Will my surgery be different if I join?

Your liver transplant operation itself will be the same, but the way your doctors decide about giving blood transfusions might be guided by the new Quantra device instead of just standard tests.

What does 'end-stage liver disease' mean?

This means your liver is very damaged and isn't working well enough to keep you healthy, often requiring a transplant.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it won't affect your medical care.

How to find out more

Guillaume PORTA BONETE, Md

porta-bonete.g@chu-toulouse.fr 561323565 Official trial record

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