Hemoglobin Levels for Blood Transfusions During and After Surgery

NCT ID: NCT06718439

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2027-01-15

Brief Summary

The goal of this pilot clinical trial is to learn if it is achievable to conduct a large-scale clinical trial whereby, the investigators will compare two ways of deciding when to give a blood transfusion during surgery. Participants in this study are adults undergoing surgery with a risk of significant blood loss.

The main question it aims to answer is:

• Is a trial designed to definitively test and compare two different red blood cell transfusion strategies feasible?

Participants will:

• Receive blood transfusions during surgery based on a higher (less than 90 g/L) or a lower (less than 70 g/L) hemoglobin value.
• Complete questionnaires at 30 and 90 days after surgery.

Detailed Description

During some surgeries, there is a risk of significant blood loss. To manage this, blood transfusions may be needed to replace lost blood.

Transfusion strategies during surgery vary among physicians and hospitals. Current guidelines are broad and suggest it is okay to limit blood transfusions during surgery. However, some anesthesiologists worry that not giving enough blood might cause problems for patients. On the other hand, many cancer surgeons are concerned that giving too much blood could lead to worse outcomes for cancer patients. This difference in opinions shows why clinical trials are needed to guide future practices.

The purpose of this study is to test a new protocol that is designed to definitively test and compare two different red blood cell transfusion strategies. It is hypothesized that this trial will be deemed feasible.

TOPGUN-Pilot is a pragmatic, individually randomized, parallel-arm, vanguard, randomized controlled trial. If feasibility is demonstrated, patients enrolled in the vanguard pilot will be rolled into the definitive TOPGUN trial. This trial is meant to be pragmatic in nature, whereby the study protocol is simple to implement, outcomes are relevant to patients, physicians, and healthcare administrators, and data collection is limited. Management of patients prior to, during, and after the intraoperative transfusion strategies will be at the discretion of individual practitioners. A total of 384 patients will be randomized across 3 hospitals (4 sites) in Ontario and Quebec.

Conditions

Blood Transfusion; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Restrictive Transfusion

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Liberal transfusion

Intervention Type: 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.

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Martel, MD, MSc, FRCSC, FACS

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Zanna Vanterpool, MSc

Role: CONTACT

zvanterpool@ohri.ca

6137378899 ext. 71484

Facility Contacts

Guillaume Martel, MD, MSc, FRCSC, FACS

Role: primary

gumartel@toh.ca

6137378899 ext. 71053

Other Identifiers

20240690-01H

Identifier Type: -

Identifier Source: org_study_id