Hemoglobin thresholds for blood transfusions during and after surgery
Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
This pilot tests whether using a higher (90 g/L) versus a lower (70 g/L) hemoglobin level to decide on red blood cell transfusions during surgery works for adults at risk of significant blood loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06718439 on ClinicalTrials.gov |
What this trial studies
This pilot, randomized and pragmatic trial assigns adults having surgery with risk of significant blood loss to one of two intraoperative transfusion strategies using either a higher hemoglobin threshold (~90 g/L) or a lower threshold (~70 g/L). Transfusions are given during surgery when hemoglobin falls below the assigned threshold, while other perioperative care is left to the treating clinicians. Participants complete short questionnaires at 30 and 90 days after surgery and will be followed for outcomes relevant to patients and health systems. If the pilot proves feasible, enrolled patients may be transitioned into a larger definitive trial.
Who should consider this trial
Good fit: Adults (age ≥18) having elective or urgent surgery with a measurable risk of red blood cell transfusion, a preoperative hemoglobin <130 g/L, and an intraoperative hemoglobin ≤100 g/L at any time are the intended candidates.
Not a fit: Patients with active major hemorrhage, recent acute coronary syndrome or myocardial infarction, cardiac or liver transplant surgery, severe traumatic brain injury, pregnancy/obstetrical surgery, those who refuse blood products, or those unable to consent are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the trial could produce clear, evidence-based rules for when to give blood during surgery, potentially reducing unnecessary transfusions or preventing under-transfusion.
How similar studies have performed: Prior trials comparing restrictive versus liberal transfusion thresholds in hospitalized and some surgical populations have often found restrictive approaches to be safe or noninferior, but high-quality definitive data specific to intraoperative management are still limited.
Eligibility criteria
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. * Liver transplantation. * Surgery for moderate to severe (Glasgow Coma Scale (GCS) score ≤ 12) traumatic brain injury. * Pregnancy or obstetrical surgery. * Patient refusal of blood products. * Inability to provide consent.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Guillaume Martel, MD, MSc, FRCSC, FACS — Ottawa Hospital Research Institute
- Study coordinator: Zanna Vanterpool, MSc
- Email: zvanterpool@ohri.ca
- Phone: 6137378899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.