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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5,058
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.
The Ottawa Hospital
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
30-day overall morbidity or mortality
Overall postoperative morbidity and mortality within 30 days after surgery, assessed using the Comprehensive Complication Index (CCI). Complications will be identified using the Postoperative Morbidity Survey (POMS) and graded according to the Clavien-Dindo classification. The CCI summarizes all postoperative complications into a continuous score ranging from 0 (no complications) to 100 (death), with higher scores indicating greater postoperative morbidity.
Time frame: From randomization to 30 days post-surgery
30-day individual perioperative complications
The occurrence of individual perioperative complications will be captured using the Postoperative Morbidity Survey (POMS). Complications will be categorized according to the POMS domains, including pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, hematological, and pain-related morbidity.
Time frame: From randomization to 30 days post-surgery
90-day mortality
All-cause mortality within 90 days after surgery, assessed through participant follow-up and review of the medical record.
Time frame: From randomization to 90 days post-surgery
Blood product transfusions (intraoperative and postoperative)
Number of and type of blood product transfusions
Time frame: From randomization to 30 days post-surgery
Change in hemoglobin
Change in hemoglobin concentration from preoperative baseline through the perioperative and postoperative period, assessed using routine laboratory measurements and reported in grams per liter (g/L).
Time frame: From preoperative to 30 days post-surgery
Estimated blood loss
Estimated blood loss in mL as noted in the operative report or anesthesia record
Time frame: During surgery
Intensive care admission
Occurrence of admission to an intensive care unit (ICU)
Time frame: From randomization to 30 days post-surgery
Post-operative length of stay
Number of days from the date of surgery to the date of discharge from the index hospitalization
Time frame: From randomization to hospital discharge (up to 30 days post-surgery)
Readmission to hospital
Occurrence of readmission to a hospital
Time frame: From discharge to 30 days post-surgery
Patient-reported disability
Functional status and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 evaluates functioning across six domains: cognition, mobility, self-care, getting along with others, life activities, and participation in society. Higher scores indicate greater disability and functional impairment.
Time frame: 30 and 90 days post-surgery
Patient-reported quality of life
Patient-reported health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L evaluates mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: 30 and 90 days post-surgery
Disease-free and overall survival (participants undergoing cancer resection)
For participants undergoing cancer resection, disease-free survival and overall survival will be assessed at 3 and 5 years after surgery through review of the electronic medical record.
Time frame: 3 and 5 years post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.