Transfusion Requirements in Cardiac Surgery

Cardiac Surgery Clinical Trial

— TRICSII  

Official title:

Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484639
• Other study ID #: TRICSII
• Secondary ID: Application #232
• Status: Completed
• Phase: N/A
• First received: November 30, 2011
• Last updated: February 20, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Liberal 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.
• Restrictive 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.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Alberta Health Services	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Nadine Shehata	Canadian Institutes of Health Research (CIHR), Health Canada

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)	baseline	No
Primary	Protocol adherence	To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions).	28 days or hospital discharge	No
Secondary	Mortality and morbidity	To determine the mortality rate and a composite outcome for morbidity (renal, cardiac, neurological and infectious adverse events).	28 days or hospital discharge	Yes
Secondary	Missing data	To determine the proportion of missing data as a measure of the feasibility of the case report form	28 days or hospital discharge	No
Secondary	Blood product utilization	To determine the proportion of blood products utilized (red cells, platelets and plasma)	28 days or hospital discharge	No