This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Transfusion Requirements in Cardiac Surgery III (TRICS-III)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT02042898
First received: January 17, 2014
Last updated: March 24, 2017
Last verified: March 2017
  Purpose
TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

Condition Intervention
Disorder; Heart, Functional, Postoperative, Cardiac Surgery Other: Restrictive Transfusion Strategy Other: Liberal transfusion strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
    Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit


Secondary Outcome Measures:
  • Incidence of in-hospital all-cause mortality [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of in-hospital myocardial infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of in-hospital new renal failure requiring dialysis [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of in-hospital new focal neurological deficit [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Length of stay in the ICU and hospital [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Duration of mechanical ventilation [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of infection [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria) [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of gut infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization) [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Death [ Time Frame: 6 months ]
  • New onset dialysis (since incident surgery) status [ Time Frame: 6 months ]
  • Stroke [ Time Frame: 6 months ]
  • Coronary revascularization [ Time Frame: 6 months ]
  • Myocardial infarction [ Time Frame: 6 months ]
  • Health Care Utilization [ Time Frame: 6 months ]
  • Renal function, based on changes in postoperative serum creatinine [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of Seizures [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of Encephalopathy [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  • Incidence of Delirium [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]

Enrollment: 5028
Actual Study Start Date: January 20, 2014
Estimated Study Completion Date: October 1, 2017
Estimated Primary Completion Date: April 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Restrictive transfusion strategy
Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin is <75 g/L (<7.5 g/dL;<4.7mmol/L) intraoperatively and/or postoperatively
Other: Restrictive Transfusion Strategy
Active Comparator: Liberal transfusion strategy
Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is <95 g/L (<9.5 g/dL<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or <85 g/L (< 8.5 g/dL;<5.3mmol/L) on the ward.
Other: Liberal transfusion strategy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Planned cardiac surgery using cardiopulmonary bypass
  • Informed consent obtained
  • Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

  • Patients who are unable to receive or who refuse blood products
  • Patients who are involved in a preoperative autologous pre-donation program
  • Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
  • Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
  • Patients who are unable to receive or who refuse blood products
  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: NCT02042898

  Show 74 Study Locations
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
Principal Investigator: David Mazer, MD St. Michael's Hospital, Toronto
Principal Investigator: Nadine Shehata, MD Mount Sinai Hospital, New York
Principal Investigator: Richard Whitlock, MD McMaster University
Principal Investigator: Dean Fergusson, MD Ottawa Hospital Research Institute
Principal Investigator: Kevin Thorpe, MSc University of Toronto
  More Information

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02042898     History of Changes
Other Study ID Numbers: TRICSIII
301852 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Study First Received: January 17, 2014
Last Updated: March 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by St. Michael's Hospital, Toronto:
Cardiac Surgery
Transfusion

ClinicalTrials.gov processed this record on July 25, 2017