Active not recruitingNAINTERVENTIONAL

Blood Salvage in Orthotopic Liver Transplantation With HCC

This study is for people having a liver transplant because of a type of liver cancer called Hepatocellular Carcinoma (HCC). During surgery, patients often lose blood. Historically, doctors were careful about giving a patient's own collected blood back to them if they had cancer, due to worries about spreading cancer cells. This study wants to find out if it is safe and effective to collect and give a patient's own blood back to them during a liver transplant for HCC. We will look at whether it helps reduce the need for donated blood and how it might affect cancer coming back. The results will help decide if a larger study is needed.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

21 Jan 2023

Estimated completion

31 Dec 2034

Hepatocellular Carcinoma Surgery

What is this study about?

When someone has a liver transplant for a type of liver cancer called Hepatocellular Carcinoma (HCC), they often lose a lot of blood during the operation. To replace this blood, doctors usually use blood donated by other people. However, using donated blood comes with certain risks.

There's a special technique called Intraoperative Blood Cell Salvage and Autotransfusion (IBSA). This involves collecting a patient's own blood during surgery, cleaning it, and then giving it back to them. While this method is often used in other surgeries to reduce the need for donated blood, it's not commonly used for cancer surgeries like liver transplants for HCC. This is because there's a theoretical concern that giving the patient their own blood back could accidentally reintroduce cancer cells into their body.

This study aims to investigate this concern. We want to see if using a patient's own blood (IBSA) during a liver transplant for HCC is safe and truly helpful. We'll look at how much donated blood is needed and whether it affects the chance of the cancer coming back. The results will help doctors decide if using this technique is a good option for patients with HCC undergoing liver transplantation in the future.

Key takeaways

This study explores using your own blood during liver transplant for HCC.
It aims to see if this method is safe and reduces the need for donated blood.
Participation involves being randomly assigned to receive or not receive your own collected blood.
The study will check for any effects on cancer recurrence and transfusion needs.
Its results will help decide if a larger study is needed in the future.

Who may be eligible?

To be considered for this study, you must be an adult (18 years or older) and be on the waiting list for a liver transplant specially because you have Hepatocellular Carcinoma (HCC), which is a common type of liver cancer. You will need to be having your first liver transplant, not a repeat one.

There are a few reasons why you wouldn't be able to join. These include if you have other types of cancer in addition to or instead of HCC, such as different kinds of liver cancer or cancer that has spread from another part of your body. Also, if you are having multiple organs transplanted at the same time, you would not be eligible.

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 currently on the waiting list for a liver transplant?
Is your liver transplant primarily due to Hepatocellular Carcinoma (HCC)?
Is this your first liver transplant (not a repeat)?
Are you not having any other major organs transplanted at the same time?
Do you not have other types of cancer in addition to or instead of HCC?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first discuss the study with the clinic staff. During your liver transplant surgery, if enough of your own blood is collected (at least one unit after it's cleaned), you will be randomly assigned to one of two groups. One group will have their cleaned blood given back to them during surgery, while the other group will have their cleaned blood safely discarded.

After your surgery, the medical team will keep a close eye on your health. They will particularly look at how much blood transfusion you needed and monitor your recovery, including whether your cancer returns or not. The total duration of your participation will involve follow-up care after your transplant, which is standard for all transplant patients.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing the amount of donated blood you receive, which could lower the risks associated with those transfusions. However, there's a theoretical risk that giving your own blood back could potentially reintroduce cancer cells, although this study aims to understand that risk better. As with any study, you have the right to withdraw at any time without explaining why, and your medical care will not be affected.

Locations (1)

University Health Network
Verified postcode
Toronto, Canada

Common questions

What is 'Hepatocellular Carcinoma (HCC)'?

HCC is the most common type of liver cancer that starts in the main cells of the liver.

What is 'blood salvage'?

Blood salvage is a process where your own blood lost during surgery is collected, cleaned, and can potentially be given back to you.

Why is this study only for people with HCC?

Doctors are particularly concerned about using blood salvage for HCC patients due to the theoretical risk of spreading cancer cells, so this study focuses on understanding that specific situation.

Will I know if I'm getting my own blood back?

You will be randomly assigned to a group, so you won't know beforehand if you'll receive your own blood back or if it will be discarded, but the medical team will be aware.

What is a 'pilot study'?

A pilot study is a smaller, initial study to check if an idea is practical, safe, and worth exploring in a larger, more detailed study later on.