Actively Recruiting
Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
Led by Ottawa Hospital Research Institute · Updated on 2025-07-31
384
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to determine if it is feasible to conduct a large-scale clinical trial comparing two different strategies for deciding when to give blood transfusions during surgery. The study focuses on adults undergoing surgeries where there is a significant risk of blood loss. It addresses concerns from doctors about whether giving too little or too much blood during surgery could affect patient outcomes. Participants will be randomly assigned to one of two transfusion strategies during surgery and up to six hours afterward in the post-anesthetic care unit. One strategy, called the restrictive transfusion approach, gives blood when hemoglobin levels drop below 70 g/L or aims to keep hemoglobin between 70-80 g/L. The other, a liberal transfusion approach, gives blood when hemoglobin levels fall below 90 g/L or aims to maintain levels between 90-100 g/L. During the study, participants will receive blood transfusions according to their assigned strategy and complete questionnaires 30 and 90 days after surgery. Researchers will monitor how many patients are recruited, how well the transfusion strategies are followed during surgery and recovery, and how many participants remain in the study up to 30 days after surgery. This pilot trial will help guide the design of a larger future trial.
CONDITIONS
Brief Title
Hemoglobin Levels for Blood Transfusions During and After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Undergoing elective or urgent surgery
- Risk of needing red blood cell transfusion of at least 10 percent
- Preoperative hemoglobin less than 130 g/L
- Intraoperative hemoglobin of 100 g/L or less at any time during surgery
You will not qualify if you...
- Active major bleeding as reason for surgery, such as ruptured aneurysm or severe trauma
- Heart attack or acute coronary syndrome within the past 6 weeks
- Undergoing cardiac surgery
- Undergoing liver transplantation
- Surgery for moderate to severe traumatic brain injury (Glasgow Coma Scale 12 or less)
- Pregnancy or obstetrical surgery
- Refusal of blood products
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery and up to 6 hours post-operative
Participants receive one of two red blood cell transfusion strategies during surgery and for up to 6 hours in the post-operative anesthesia care unit to manage hemoglobin levels.
1 hospital stay including surgery and immediate post-operative care
Duration - 30 days post surgery
Participants are monitored for outcomes and retention up to 30 days after surgery.
Follow-up visits as scheduled up to 30 days after surgery
Trial Site Locations
Total: 1 location
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
Z
Zanna Vanterpool, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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