Blood Transfusion for Major Surgery
(TOPGUN Trial)
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?
Guillaume Martel, MD, MSc, FRCSC, FACS
Principal Investigator
Ottawa Hospital Research Institute
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive blood transfusions to maintain specific hemoglobin levels during surgery and in the recovery room
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of morbidity, mortality, and quality of life
Long-term follow-up
For participants undergoing cancer resection, disease-free and overall survival will be assessed
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
The restrictive transfusion strategy will consist of administering red blood cell transfusion when the participant's hemoglobin level is measured below 70 g/L or to maintain a hemoglobin target range of 70-80 g/L.
The liberal transfusion strategy will consist of administering red blood cell transfusion when the participant's hemoglobin level is measured below 90 g/L or to maintain a hemoglobin target range of 90-100 g/L.ed to during surgery and up to 6 hours in the post-operative anesthesia care unit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
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