Cardiac Surgery
Conditions
Keywords
transfusion, cardiac surgery
Brief summary
This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a restrictive transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a liberal transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward. The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma). The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.
Interventions
OTHERLiberal transfusion triggers
Patients allocated to a liberal transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.
OTHERRestrictive transfusion triggers
Patients allocated to a restrictive transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively.
Sponsors
Canadian Institutes of Health Research (CIHR)
Health Canada
Nadine Shehata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more * Consent
Exclusion criteria
* Pregnancy * Refusal of blood products * Participating in autologous blood donation program * Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | baseline | To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached) |
| Protocol adherence | 28 days or hospital discharge | To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality and morbidity | 28 days or hospital discharge | To determine the mortality rate and a composite outcome for morbidity (renal, cardiac, neurological and infectious adverse events). |
| Missing data | 28 days or hospital discharge | To determine the proportion of missing data as a measure of the feasibility of the case report form |
| Blood product utilization | 28 days or hospital discharge | To determine the proportion of blood products utilized (red cells, platelets and plasma) |
Countries
Canada, United States
Outcome results
None listed