Blood Transfusion Strategies During Major Surgery

NCT07748663 | Not Yet Recruiting DMC

• 2 other identifiers: CTO 573620260417-01T
• Study Type: interventional
• Target: 5,058
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization to 30 days post-surgery

Secondary Outcomes (11)

• 30-day individual perioperative complications

  From randomization to 30 days post-surgery

• 90-day mortality

  From randomization to 90 days post-surgery

• Blood product transfusions (intraoperative and postoperative)

  From randomization to 30 days post-surgery

• Change in hemoglobin

  From preoperative to 30 days post-surgery

• Estimated blood loss

  During surgery

Study Arms (2)

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.

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.

Procedure: Liberal transfusion

Interventions

Restrictive Transfusion PROCEDURE

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.

Restrictive transfusion strategy

Liberal transfusion PROCEDURE

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.

Liberal transfusion strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (2)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Study Officials

• Guillaume Martel, MD, MSc, FRCSC, FACS

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Daniel McIsaac, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zanna L Vanterpool, Msc

CONTACT

613-737-8899; zvanterpool@ohri.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 19, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2035
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication
• Access Criteria: Qualified researchers may access coded individual participant data and relevant supporting study documents upon reasonable request. Requests must be submitted to the Principal Investigator and include a detailed research proposal. Access will be subject to review and approval by the Study Steering Committee, institutional review boards (if applicable), and execution of a signed data access agreement.

Locations

CA (2)