Clinical trial NCT01484639: Transfusion Requirements in Cardiac Surgery
Official title: Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: transfusion
cardiac surgery
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Health Canada
First posted: 2011-12-02
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Enrollment rate
timeFrame: baseline
measure: Protocol adherence
timeFrame: 28 days or hospital discharge
Secondary outcomes:
measure: Mortality and morbidity
timeFrame: 28 days or hospital discharge
measure: Missing data
timeFrame: 28 days or hospital discharge
measure: Blood product utilization
timeFrame: 28 days or hospital discharge
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Health Services
state: Alberta
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
Study officials:
affiliation: Li Ka Shing Knowledge Institute, Mount Sinai Hospital
name: Nadine Shehata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: David Mazer, MD
role: PRINCIPAL_INVESTIGATOR
References: