Hemoglobin Levels for Blood Transfusions During and After Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Liver transplantation.
Trial design
Design model
Parallel
Treatments tested in this trial
Restrictive Transfusion
Procedure/SurgeryRed 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/SurgeryRed 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.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: Restrictive transfusion strategyExperimental treatment 1 intervention
Group B: Liberal transfusion strategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment of ≥8 patients per month per site for one year.
Time frame
12 months post site initiation2
Intervention adherence
Intervention adherence of at least 85%.
Time frame
From enrollment up to 6 hours in the Post-Anesthetic Care Unit3
Participant retention
Retention of at least 90% of participants with completion of 30-day effectiveness outcomes.
Time frame
From randomization to 30 days post surgery.Sponsors and contacts
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Source ClinicalTrials.gov