Transfusion Requirements in Cardiac Surgery (TRICSII)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Health Canada
Information provided by (Responsible Party):
Nadine Shehata, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01484639
First received: November 30, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Cardiac Surgery
Other: Liberal transfusion triggers
Other: Restrictive transfusion triggers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Transfusion Requirements in Cardiac Surgery (TRICS II): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Enrollment rate [ Time Frame: baseline ] [ Designated as safety issue: No ]
    To determine enrollment rates (patients enrolled/patients eligible), consent rates (consent obtained/patients approached)

  • Protocol adherence [ Time Frame: 28 days or hospital discharge ] [ Designated as safety issue: No ]
    To determine protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions).


Secondary Outcome Measures:
  • Mortality and morbidity [ Time Frame: 28 days or hospital discharge ] [ Designated as safety issue: Yes ]
    To determine the mortality rate and a composite outcome for morbidity (renal, cardiac, neurological and infectious adverse events).

  • Missing data [ Time Frame: 28 days or hospital discharge ] [ Designated as safety issue: No ]
    To determine the proportion of missing data as a measure of the feasibility of the case report form

  • Blood product utilization [ Time Frame: 28 days or hospital discharge ] [ Designated as safety issue: No ]
    To determine the proportion of blood products utilized (red cells, platelets and plasma)


Enrollment: 208
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484639

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Alberta Health Services
Edmonton, Alberta, Canada, T6G2B7
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
St Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Nadine Shehata
Canadian Institutes of Health Research (CIHR)
Health Canada
Investigators
Principal Investigator: Nadine Shehata, MD Li Ka Shing Knowledge Institute, Mount Sinai Hospital
Principal Investigator: David Mazer, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Nadine Shehata, Principal Investigator-Sponsor, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01484639     History of Changes
Other Study ID Numbers: TRICSII, Application #232416
Study First Received: November 30, 2011
Last Updated: February 20, 2013
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
transfusion
cardiac surgery

ClinicalTrials.gov processed this record on October 23, 2014