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NCT Number: NCT06718439

Hemoglobin Levels for Blood Transfusions During and After Surgery

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.

Recruiting

Interested in participating?

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Key information

Conditions

Blood Transfusion Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location status: Recruiting

Location contact

Guillaume Martel, MD, MSc, FRCSC, FACS

CONTACT

[email protected]

6137378899 ext. 71053

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 12 months post site initiation

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

  2. Intervention adherence

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

    Intervention adherence of at least 85%.

  3. Participant retention

    Time frame: From randomization to 30 days post surgery.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Zanna Vanterpool, MSc

CONTACT

[email protected]

6137378899 ext. 71484

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)

Acronym: TOPGUN-Pilot

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 5, 2024
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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