Perioperative Red Blood Cell Transfusion
Conditions
Keywords
Anesthesiology, Blood Transfusion, Cancer Outcomes, Perioperative Care, Perioperative Complications, Surgery
Brief summary
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.
Interventions
PROCEDURERestrictive 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.
PROCEDURELiberal 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.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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, 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 * Sickle cell disease (sickle cell trait is allowed) * Pregnancy or obstetrical surgery * Patient refusal of blood products * Inability to provide consent * Previous randomization in the TOPGUN(-Pilot) trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day overall morbidity or mortality | From randomization to 30 days post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day individual perioperative complications | From randomization to 30 days post-surgery | 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. |
| 90-day mortality | From randomization to 90 days post-surgery | All-cause mortality within 90 days after surgery, assessed through participant follow-up and review of the medical record. |
| Blood product transfusions (intraoperative and postoperative) | From randomization to 30 days post-surgery | Number of and type of blood product transfusions |
| Change in hemoglobin | From preoperative to 30 days post-surgery | 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). |
| Estimated blood loss | During surgery | Estimated blood loss in mL as noted in the operative report or anesthesia record |
| Intensive care admission | From randomization to 30 days post-surgery | Occurrence of admission to an intensive care unit (ICU) |
| Post-operative length of stay | From randomization to hospital discharge (up to 30 days post-surgery) | Number of days from the date of surgery to the date of discharge from the index hospitalization |
| Readmission to hospital | From discharge to 30 days post-surgery | Occurrence of readmission to a hospital |
| Patient-reported disability | 30 and 90 days post-surgery | 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. |
| Patient-reported quality of life | 30 and 90 days post-surgery | 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. |
| Disease-free and overall survival (participants undergoing cancer resection) | 3 and 5 years post-surgery | 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. |
Countries
Canada
Contacts
CONTACTZanna L Vanterpool, Msc
PRINCIPAL_INVESTIGATORGuillaume Martel, MD, MSc, FRCSC, FACS
Ottawa Hospital Research Institute
PRINCIPAL_INVESTIGATORDaniel McIsaac, MD
The Ottawa Hospital
Outcome results
None listed