Active not recruitingNAINTERVENTIONAL

Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections

This study aims to make major liver surgeries safer by reducing the need for blood transfusions. Surgeons often remove parts of the liver to treat diseases like cancer, but this can lead to significant blood loss. The study investigates a technique called hypovolemic phlebotomy. This involves temporarily lowering your blood pressure by carefully removing a small amount of blood before the surgery. The idea is that this might reduce bleeding during the operation, meaning fewer patients would need blood transfusions. Needing a blood transfusion can sometimes lead to complications and might even affect long-term recovery for patients undergoing liver surgery.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ottawa Hospital Research Institute

Enrolment target

440

Start

28 Sep 2018

Estimated completion

01 Jan 2026

Liver Neoplasms Hepatectomy Blood Transfusion Blood Loss, Surgical

What is this study about?

When you have a serious liver problem, sometimes the best way to help is to have an operation called a major liver resection. This is when surgeons carefully remove a part of your liver. These operations are often done to treat liver cancers or other serious conditions. While these surgeries can be life-saving, they can also cause a fair amount of bleeding during the procedure. When someone loses too much blood, they might need a blood transfusion, where they receive blood from a donor.

Doctors are always looking for ways to make surgeries safer and recovery smoother. Blood transfusions, while often necessary and life-saving, can sometimes come with their own risks or complications. There's also some thought that receiving a transfusion during liver cancer surgery might even affect how well you recover in the long run. Because of this, anything that can reduce the need for transfusions during these important operations would be a big step forward.

This study is looking into a simple technique called 'hypovolemic phlebotomy'. Don't worry about the big name! It essentially means doctors will carefully take a small amount of your own blood, usually before the surgery starts. This temporarily lowers your blood pressure a little. The hope is that by doing this, less blood will be lost during the liver surgery itself. If less blood is lost, then fewer patients will need a blood transfusion. The study wants to see if this method really works and how safe and effective it is for people having major liver surgery.

Key takeaways

This study aims to reduce blood transfusions during major liver surgery.
It tests if temporarily lowering blood pressure before surgery helps reduce bleeding.
Participation involves being randomly assigned to a treatment or control group.
The study focuses on adults having liver resections for various conditions.
Reducing transfusions may lead to safer surgeries and better recovery.

Who may be eligible?

This study is looking for adults aged 18 or older who are planning to have a major liver operation. This means you’re having a significant part of your liver removed, for example, if you have liver cancer or another condition that requires this type of surgery.

There are certain reasons why you might not be able to join the study. For instance, if you're under 18 or if your blood counts are too low before surgery. Also, if you have serious heart or brain conditions, certain kidney problems, or if your blood doesn't clot properly, you wouldn't be able to take part. This also applies if you're pregnant, have an active infection, or if you refuse blood products for any reason.

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 major liver operation?
Do you have good kidney function?
Are you free from serious heart or brain conditions?
Are your blood clotting factors generally normal?
Are you not pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be randomly assigned to one of two groups, like flipping a coin. One group would receive the special treatment called 'hypovolemic phlebotomy' along with standard care. This means a small amount of your blood would be carefully taken before your liver surgery. The other group would just receive the standard care for your liver surgery, without the phlebotomy.

Doctors will carefully watch your blood loss during surgery and check if you need any blood transfusions. They will also look at how you recover in the 30 days after your operation, checking for any complications or if you need other blood products. During this time, they’ll monitor your general health and how well the treatment worked. This follow-up would typically involve your usual post-surgery hospital stays and any planned outpatient appointments.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the 'hypovolemic phlebotomy' technique proves to reduce blood loss and the need for transfusions during your surgery. This could lead to a smoother recovery. However, like any medical procedure, there are potential risks, though unlikely, associated with temporarily lowering blood pressure or taking blood. These would be carefully explained to you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Vancouver General Hospital
Verified postcode
Vancouver, Canada
The Ottawa Hospital
Verified postcode
Ottawa, Canada
Centre Hospitalier de l"Université de Sherbrooke
Verified postcode
Montreal, Canada
Centre Hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada

Common questions

What is 'hypovolemic phlebotomy'?

It's a procedure where a small amount of your blood is carefully removed before surgery to temporarily lower your blood pressure, hoping to reduce bleeding during the operation.

Why is reducing blood transfusions important?

While transfusions are often necessary, they can sometimes have complications. Reducing the need for them can make surgery safer and possibly improve recovery.

Will I definitely get the new treatment if I join?

No. You'll be randomly assigned to either receive the new treatment plus standard care, or just standard care, like drawing from a hat.

How long will I be followed in the study?

Doctors will monitor your recovery and any need for blood products for up to 30 days after your surgery.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point without it affecting your medical care.