Blood Transfusion Strategies During Major Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Restrictive Transfusion
- Liberal transfusion
Treatment groups
5,058 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov