Not yet recruitingOBSERVATIONAL

Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project

This study looks at ways to reduce the need for blood transfusions in adults undergoing liver surgery at Kingston Health Sciences Centre. We're investigating a method where a small amount of a patient's blood (about 10%) is carefully removed before surgery and then given back afterwards. This technique, called 'controlled blood removal' or 'hypovolemic phlebotomy,' builds on a previous study. Our team will also closely monitor patients during and after surgery to see how their body responds, checking things like oxygen levels, urine output, and how they recover. We'll track complications, how long they stay in hospital, and their health for up to 90 days. We'll also compare long-term liver cancer return rates in these patients to those who had surgery in the past without this blood removal method.

At a glance

Status

Not yet recruiting

Sponsor

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Jun 2031

Hepatectomy Transfusion Requirements Intraoperative Bleeding Intraoperative Monitoring Blood Cells Transfusion Phlebotomy

What is this study about?

When people have surgery on their liver, there's often a risk of bleeding, and sometimes a blood transfusion is needed. Blood transfusions can be life-saving, but doctors are always looking for ways to reduce the need for them, as they come with their own set of potential risks and costs.

This study is all about trying a new way to reduce the amount of blood lost during liver surgery, and hopefully, reduce the need for transfusions. The main idea is that before the liver removal surgery begins, a small, carefully measured amount of the patient's own blood – about 10% – is taken out. This blood is safely stored and then given back to the patient once the main part of the liver surgery is complete. The hope is that by temporarily reducing the amount of blood circulating in the body, there might be less bleeding during the tricky parts of the operation.

Beyond just seeing if this 'controlled blood removal' helps, our team will also be monitoring patients very closely during surgery. We'll be looking at various blood tests to understand how the body is coping, and we'll have clear guidelines for how fluids and blood pressure medicines are used. After surgery, we'll keep a close eye on your recovery, checking for any problems, how long you stay in hospital, and your general health for up to three months. We'll also compare how likely liver cancer is to return in the long term for people in this study versus previous patients who didn't have this procedure.

Key takeaways

This study aims to reduce blood transfusions during liver surgery.
It involves temporarily removing and then returning a small amount of your own blood.
Your health will be closely monitored during and for 90 days after surgery.
The study also compares long-term liver cancer outcomes.
Participation is voluntary and won't affect your standard medical care.
This research contributes to safer liver surgery practices.

Who may be eligible?

To be considered for this study, you would need to be an adult undergoing liver surgery that involves three or more sections of the liver, and where it's expected you might lose more than a cup of blood. If you have known liver scarring (cirrhosis), surgery on even one full section of the liver could make you eligible.

There are certain health conditions that would mean you couldn't take part. These include recent heart problems, a stroke in the past six months, or significant blood vessel disease that causes ongoing pain. You also couldn't participate if you are pregnant, have an active infection, have low blood counts (like too few red blood cells or platelets), or kidney problems. If you've had a bad reaction to blood removal or transfusion before, or if you're having emergency surgery, you wouldn't be able to join. Finally, if you've been in this study previously or know you can't attend follow-up appointments, you wouldn't 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 an adult aged 18 or older?
Are you having a liver surgery involving 3 or more sections of the liver?
Do you have any recent serious heart problems or a stroke in the last 6 months?
Are you currently pregnant?
Do you have very low blood counts (e.g., severe anaemia or low platelets)?
Have you had other severe health issues like active infection or serious kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo the controlled blood removal procedure just before your liver surgery begins. This involves a small amount (about 10%) of your blood being temporarily removed and then returned to you after the main part of the surgery. During your surgery, medical staff will carefully monitor your body's response using additional blood tests and keeping a close eye on your urine output. After your surgery, the research team will keep track of your recovery, including any complications, how long you stay in the hospital, and your overall health for up to 90 days. This will involve regular check-ups and possibly questionnaires during this period. We will also compare the long-term chance of liver cancer coming back in people who participate versus those who didn't.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the controlled blood removal might reduce your need for a blood transfusion during liver surgery. It could also lead to doctors understanding more about how to make liver surgeries safer for everyone. However, there are potential risks associated with temporarily removing and reinfusing blood, such as temporary dizziness or discomfort, though these are closely monitored. As with any medical procedure, there's also a small risk of infection or other unexpected reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Kingston Health Sciences Centre
Verified postcode
Kingston, Canada

Common questions

What is 'controlled blood removal'?

It's when a small amount of your blood (about 10%) is carefully taken out before your liver surgery and then given back to you after the main part of the operation.

Why are you doing this study?

We are trying to find out if this method can reduce the need for blood transfusions during liver surgery, making the procedure safer for patients.

Will I still get a blood transfusion if I need one?

Yes, if your medical team determines you need a blood transfusion for your safety during or after surgery, you will still receive one, regardless of your participation in the study.

How long will I be followed up after my surgery?

The study team will monitor your recovery and health for up to 90 days after your surgery. They will also look at long-term cancer recurrence rates.

Can I decide not to participate?

Yes, taking part is completely your choice. You can decide not to participate, or withdraw at any time, and it won't affect your medical care.

How to find out more

Glenio Mizubuti, MD, PhD, FRCPC

glenio.mizubuti@kingstonhsc.ca (613) 548-7827 Official trial record

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