Cardiac Surgery Clinical Trial
Official title:
Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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