Blood Transfusion for Major Surgery

(TOPGUN Trial)

Not yet recruiting at 1 trial location
ZL
Overseen ByZanna L Vanterpool, Msc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized clinical trial is to address the uncertainty surrounding blood transfusion strategies in the operating room for adult patients undergoing major surgery. The main question it aims to answer is:

Does a higher hemoglobin threshold for blood transfusion during surgery reduce the risk of serious complications or death after surgery compared with a lower hemoglobin threshold?

Researchers will compare a liberal and a restrictive transfusion strategy during surgery and the first few hours of recovery.

Participants will be randomly assigned to one of two blood transfusion strategies. Blood transfusions will be given to maintain either a higher hemoglobin level (90-100 g/L) or a lower hemoglobin level (70-80 g/L) during surgery and while in the recovery room after surgery. Participants will also complete questionnaires about their quality of life and recovery at 30 and 90 days after surgery.

Who Is on the Research Team?

GM

Guillaume Martel, MD, MSc, FRCSC, FACS

Principal Investigator

Ottawa Hospital Research Institute

DM

Daniel McIsaac, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

This trial is for adults having major surgery who may need a blood transfusion during or shortly after their operation. People with certain medical conditions or reasons that make it unsafe to join will not be included.

Inclusion Criteria

I have at least a 10% risk of needing a red blood cell transfusion.
My hemoglobin dropped below 100 g/L during surgery.
Preoperative hemoglobin of less than 130 g/L
See 2 more

Exclusion Criteria

I have had a recent heart attack or acute heart problem in the last 6 weeks.
I have had heart, lung, or liver transplant or surgery for these organs.
Previous randomization in the TOPGUN(-Pilot) trial
See 6 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two ways of giving blood transfusions during and just after major surgery: one group gets transfusions at a higher hemoglobin level (liberal), while the other waits until levels are lower (restrictive). Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Restrictive transfusion strategyExperimental Treatment1 Intervention
Group II: Liberal transfusion strategyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+