Hemoglobin Levels for Blood Transfusions During and After Surgery

NCT06718439 | Recruiting DMC

• 1 other identifier: 20240690-01H
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Transfusion; Surgery

Keywords

Red blood cell transfusion; hemoglobin threshold; blood loss management; liberal transfusion practice; restrictive transfusion practice; intraoperative

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Recruitment of ≥8 patients per month per site for one year.

  12 months post site initiation

• Intervention adherence

  Intervention adherence of at least 85%.

  From enrollment up to 6 hours in the Post-Anesthetic Care Unit

• Participant retention

  Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.

  From randomization to 30 days post 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.

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.
• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Study Officials

• Guillaume Martel, MD, MSc, FRCSC, FACS

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zanna Vanterpool, MSc

CONTACT

6137378899; 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: November 25, 2024
• First Posted: December 5, 2024
• Study Start: April 16, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CA (1)