Transfusion Requirements in Cardiac Surgery
- Conditions
- Cardiac Surgery
- Registration Number
- NCT01484639
- Lead Sponsor
- Nadine Shehata
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
- 18 years or older
- European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more
- Consent
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Blood product utilization 28 days or hospital discharge To determine the proportion of blood products utilized (red cells, platelets and plasma)
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
Trial Locations
- Locations (8)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Alberta Health Services
🇨🇦Edmonton, Alberta, Canada
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Virginia Commonwealth University🇺🇸Richmond, Virginia, United States