Blood Transfusion Thresholds During Major Surgery
Official title: The TOPGUN Trial: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion
Run by Ottawa Hospital Research Institute · NCT07748663 · Data updated 2026-11-12
This study tests whether a higher versus lower blood transfusion threshold during surgery helps reduce serious complications or death after major surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5058 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 2 sites (Ottawa, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | March 31, 2030 |
| Study ends | March 31, 2035 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07748663 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older undergoing elective or urgent major surgery with a risk of red blood cell transfusion and low preoperative hemoglobin (<130 g/L).
✕Probably not a fit
Patients who have active major bleeding, recent acute coronary events, certain organ transplants, traumatic brain injury, pregnancy, or inability to consent may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized study compares liberal and restrictive transfusion strategies in adults undergoing major surgery, focusing on intraoperative and early recovery periods. Participants are assigned to maintain a higher hemoglobin target (90–100 g/L) or a lower target (70–80 g/L) during surgery and the immediate recovery phase. The trial also collects quality-of-life and recovery data at 30 and 90 days post-surgery to understand broader outcomes. The goal is to see if a more conservative transfusion approach is as safe or safer than a liberal approach in this perioperative setting.
Why it matters
Potential benefit: If successful, the trial could define safer, more precise transfusion practices that reduce complications and improve recovery after major surgery.
How similar studies have gone: Prior research has explored transfusion thresholds, but this trial addresses perioperative use with specific intraoperative and recovery targets in a randomized design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, age ≥18. * Elective or urgent surgery. * Risk of red blood cell transfusion of at least 10 percent. * Preoperative hemoglobin of less than 130 g/L. * Intraoperative hemoglobin of \< 100 g/L at any time during surgery. Exclusion Criteria: * Active major hemorrhage as indication for surgery (e.g. ruptured aneurysm, polytrauma, etc.) * Acute coronary syndrome or myocardial infarction within the past 6 weeks. * Cardiac surgery, lung transplantation, or liver transplantation as the indication for surgery (a history of such surgery is allowed) * Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury * Sickle cell disease (sickle cell trait is allowed) * Pregnancy or obstetrical surgery * Patient refusal of blood products * Inability to provide consent * Previous randomization in the TOPGUN(-Pilot) trial
Where it's running
-
The Ottawa Hospital
Ottawa, Ontario, Canada Recruiting -
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada Not yet recruiting
Study contacts
- Principal investigator: Guillaume Martel, MD, MSc, FRCSC, FACS — Ottawa Hospital Research Institute
- Study coordinator: Zanna L Vanterpool, Msc
- Email: zvanterpool@ohri.ca
- Phone: 613-737-8899
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.