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Not yet recruiting NCT07748663

Blood Transfusion Strategies During Major Surgery

No phase Interventional Perioperative Red Blood Cell Transfusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Restrictive Transfusion, Liberal transfusion.
Who it may be relevant to
Registry conditions: Perioperative Red Blood Cell Transfusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The TOPGUN Trial: Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion

Overview

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.

Interventions

  • Procedure 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.
  • 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.

Primary outcome measures

  • 30-day overall morbidity or mortality [Time frame: From randomization to 30 days post-surgery]
Secondary outcome measures (11)
  • 30-day individual perioperative complications [Time frame: From randomization to 30 days post-surgery]
  • 90-day mortality [Time frame: From randomization to 90 days post-surgery]
  • Blood product transfusions (intraoperative and postoperative) [Time frame: From randomization to 30 days post-surgery]
  • Change in hemoglobin [Time frame: From preoperative to 30 days post-surgery]
  • Estimated blood loss [Time frame: During surgery]
  • Intensive care admission [Time frame: From randomization to 30 days post-surgery]
  • Post-operative length of stay [Time frame: From randomization to hospital discharge (up to 30 days post-surgery)]
  • Readmission to hospital [Time frame: From discharge to 30 days post-surgery]
  • Patient-reported disability [Time frame: 30 and 90 days post-surgery]
  • Patient-reported quality of life [Time frame: 30 and 90 days post-surgery]
  • Disease-free and overall survival (participants undergoing cancer resection) [Time frame: 3 and 5 years post-surgery]

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, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • The Ottawa Hospital — Ottawa
  • Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT07748663 · CTO 5736 · 20260417-01T

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗