Menu
Recruiting NCT06718439

Hemoglobin Levels for Blood Transfusions During and After Surgery

No phase Interventional Blood Transfusion Surgery

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: Blood Transfusion, Surgery. 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

  • 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.]

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.

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 · 1 center
  • The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT06718439 · 20240690-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗