Recruiting

Transfusion Strategies

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06718439

Conditions

Blood Transfusion

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Restrictive Transfusion

Liberal transfusion

Study Details

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

Study ID

NCT06718439

Start date

Apr 16, 2025

Status verified date

Jul, 2025

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Apr 15, 2026

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.
  • 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.

Study Design

Enrollment

384 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.

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

  • Recruitment rate [ Time Frame: 12 months post site initiation ]
  • Intervention adherence [ Time Frame: From enrollment up to 6 hours in the Post-Anesthetic Care Unit ]
  • Participant retention [ Time Frame: From randomization to 30 days post surgery. ]

Central Contacts and Locations

Central contacts

Zanna Vanterpool, MSc

6137378899zvanterpool@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Guillaume Martel, MD, MSc, FRCSC, FACS

6137378899gumartel@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-31.