Recruiting

Liberal & Restrictive

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07748663

Conditions

Perioperative Red Blood Cell Transfusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Restrictive Transfusion

Liberal transfusion

Study Details

Brief 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. 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?

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

Study ID

NCT07748663

Start date

Sep 2, 2026

Status verified date

Jul, 2026

Completion date

Mar 31, 2035

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5058 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Restrictive transfusion strategy

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.

experimental: Liberal transfusion strategy

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.

Interventions

Restrictive 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.

Liberal transfusion

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.

Primary outcome measure

  • 30-day overall morbidity or mortality [ Time Frame: From randomization to 30 days post-surgery ]

Central Contacts and Locations

Central contacts

Zanna L Vanterpool, Msc

613-737-8899zvanterpool@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Zanna L Vanterpool, MSc

613-737-8899zvanterpool@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Oct 22, 2026

Last verified

Jul, 2026

Keywords

  • Anesthesiology
  • Blood Transfusion
  • Cancer Outcomes
  • Perioperative Care
  • Perioperative Complications
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.