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Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
The goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. Participants in this study are adults undergoing surgery with a risk of significant blood loss. The main question it aims to answer is: * Is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible? Participants will: * Receive blood transfusions during surgery based on a higher (less than 90 g/L) or a lower (less than 70 g/L) hemoglobin value. * Complete questionnaires at 30 and 90 days after surgery.
During some surgeries, there is a risk of significant blood loss. To manage this, blood transfusions may be needed to replace lost blood. Transfusion strategies during surgery vary among physicians and hospitals. Current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. However, some anesthesiologists worry that not giving enough blood might cause problems for patients. On the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. This difference in opinions shows why clinical trials are needed to guide future practices. The purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. It is hypothesized that this trial will be deemed feasible. TOPGUN-Pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. If feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive TOPGUN trial. This trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. Management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. A total of 384 patients will be randomized across 3 hospitals (4 sites) in Ontario and Quebec.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
April 16, 2025
Primary Completion Date
April 15, 2026
Completion Date
January 15, 2027
Last Updated
July 31, 2025
384
ESTIMATED participants
Restrictive Transfusion
PROCEDURE
Liberal transfusion
PROCEDURE
Lead Sponsor
Ottawa Hospital Research Institute
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04246463