Hemoglobin Levels for Blood Transfusions During and After Surgery
Threshold for Operative and Postoperative Hemoglobin Trigger for Red Blood Cell Transfusion: A Pilot Randomized Controlled Trial (TOPGUN-Pilot)
Ottawa Hospital Research Institute
384 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria8
- 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.
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Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06718439