Perioperative Red Blood Cell TransfusionTOPGUNNCT07748663
Blood Transfusion Strategies During Major Surgery
A study testing Restrictive Transfusion and Liberal transfusion in people with Perioperative Red Blood Cell Transfusion, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
The goal of this randomized clinical trial is to address the uncertainty surrounding blood transfusion strategies in the operating room for adult patients undergoing major surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Red Blood Cell Transfusion
- What is being tested?
- Restrictive Transfusion and Liberal transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,058 participants
- Where
- 2 sitesCanada
- Study dates
- 2 Sep 2026to 31 Mar 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Patient refusal of blood products
- Inability to provide consent
- Previous randomization in the TOPGUN(-Pilot) trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Not yet recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
François M Carrier, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Zanna L Vanterpool, MSc, 613-737-8899 ext. 71484, zvanterpool@ohri.ca
About this study
Official title: The TOPGUN Trial: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion
The goal of this randomized clinical trial is to address the uncertainty surrounding blood transfusion strategies in the operating room for adult patients undergoing major surgery. The main question it aims to answer is:
Does a higher hemoglobin threshold for blood transfusion during surgery reduce the risk of serious complications or death after surgery compared with a lower hemoglobin threshold?
Read more
Researchers will compare a liberal and a restrictive transfusion strategy during surgery and the first few hours of recovery.
Participants will be randomly assigned to one of two blood transfusion strategies. Blood transfusions will be given to maintain either a higher hemoglobin level (90-100 g/L) or a lower hemoglobin level (70-80 g/L) during surgery and while in the recovery room after surgery. Participants will also complete questionnaires about their quality of life and recovery at 30 and 90 days after surgery.
- Conditions
- Perioperative Red Blood Cell Transfusion
- Being tested
- Restrictive Transfusion, Liberal transfusion
- Keywords
- Anesthesiology, Blood Transfusion, Cancer Outcomes, Perioperative Care, Perioperative Complications, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive TransfusionProcedure or surgery
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.
Liberal transfusionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive transfusion strategy | Experimental | 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. Receives: Procedure: Restrictive Transfusion |
| Liberal transfusion strategy | Experimental | 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.ed to during surgery and up to 6 hours in the post-operative anesthesia care unit. Receives: Procedure: Liberal transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day overall morbidity or mortality
Overall postoperative morbidity and mortality within 30 days after surgery, assessed using the Comprehensive Complication Index (CCI). Complications will be identified using the Postoperative Morbidity Survey (POMS) and graded according to the Clavien-Dindo classification. The CCI summarizes all postoperative complications into a continuous score ranging from 0 (no complications) to 100 (death), with higher scores indicating greater postoperative morbidity.
Measured: From randomization to 30 days post-surgery
Secondary outcomes (11)
30-day individual perioperative complications
The occurrence of individual perioperative complications will be captured using the Postoperative Morbidity Survey (POMS). Complications will be categorized according to the POMS domains, including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, hematological, and pain-related morbidity.
Measured: From randomization to 30 days post-surgery
90-day mortality
All-cause mortality within 90 days after surgery, assessed through participant follow-up and review of the medical record.
Measured: From randomization to 90 days post-surgery
Blood product transfusions (intraoperative and postoperative)
Number of and type of blood product transfusions
Measured: From randomization to 30 days post-surgery
Change in hemoglobin
Change in hemoglobin concentration from preoperative baseline through the perioperative and postoperative period, assessed using routine laboratory measurements and reported in grams per liter (g/L).
Measured: From preoperative to 30 days post-surgery
Estimated blood loss
Estimated blood loss in mL as noted in the operative report or anesthesia record
Measured: During surgery
Intensive care admission
Occurrence of admission to an intensive care unit (ICU)
Measured: From randomization to 30 days post-surgery
Post-operative length of stay
Number of days from the date of surgery to the date of discharge from the index hospitalization
Measured: From randomization to hospital discharge (up to 30 days post-surgery)
Readmission to hospital
Occurrence of readmission to a hospital
Measured: From discharge to 30 days post-surgery
Patient-reported disability
Functional status and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 evaluates functioning across six domains: cognition, mobility, self-care, getting along with others, life activities, and participation in society. Higher scores indicate greater disability and functional impairment.
Measured: 30 and 90 days post-surgery
Patient-reported quality of life
Patient-reported health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 30 and 90 days post-surgery
Disease-free and overall survival (participants undergoing cancer resection)
For participants undergoing cancer resection, disease-free survival and overall survival will be assessed at 3 and 5 years after surgery through review of the electronic medical record.
Measured: 3 and 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start2 Sep 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Red Blood Cell TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,058 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Martel, MD, MSc, FRCSC, FACS, Principal investigator, Ottawa Hospital Research InstituteDaniel McIsaac, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748663
- Sponsor's protocol ID
- CTO 5736
- Other IDs
- 20260417-01T
- Acronym
- TOPGUN
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded individual participant data from this study will be made available upon reasonable request.