An interventional study of Restrictive Transfusion and Liberal transfusion in Blood Transfusion and Surgery, sponsored by Ottawa Hospital Research Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: Restrictive Transfusion
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.
Procedure: Liberal transfusion
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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit.
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. This strategy will be adhered to during surgery and up to 6 hours in the post-operative anesthesia care unit.
Recruitment rate
Recruitment of ≥8 patients per month per site for one year.
Time frame: 12 months post site initiation
Intervention adherence
Intervention adherence of at least 85%.
Time frame: From enrollment up to 6 hours in the Post-Anesthetic Care Unit
Participant retention
Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.
Time frame: From randomization to 30 days post surgery.
Plan to share: Undecided
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Ottawa Hospital Research Institute