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Transfusion Requirements in Cardiac Surgery III (TRICS-III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02042898
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Disorder; Heart, Functional, Postoperative, Cardiac Surgery Other: Restrictive Transfusion Strategy Other: Liberal transfusion strategy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5028 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Actual Study Start Date : January 20, 2014
Actual Primary Completion Date : April 28, 2017
Actual Study Completion Date : October 1, 2017

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Incidence of in-hospital all-cause mortality [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  2. Incidence of in-hospital myocardial infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  3. Incidence of in-hospital new renal failure requiring dialysis [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  4. Incidence of in-hospital new focal neurological deficit [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  5. Length of stay in the ICU and hospital [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  6. 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) ]
  7. Duration of mechanical ventilation [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  8. Incidence of infection [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  9. Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria) [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  10. Incidence of gut infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  11. 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) ]
  12. Death [ Time Frame: 6 months ]
  13. New onset dialysis (since incident surgery) status [ Time Frame: 6 months ]
  14. Stroke [ Time Frame: 6 months ]
  15. Coronary revascularization [ Time Frame: 6 months ]
  16. Myocardial infarction [ Time Frame: 6 months ]
  17. Health Care Utilization [ Time Frame: 6 months ]
  18. Renal function, based on changes in postoperative serum creatinine [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  19. Incidence of Seizures [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  20. Incidence of Encephalopathy [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]
  21. Incidence of Delirium [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042898


Locations
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Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: David Mazer, MD Unity Health Toronto
Principal Investigator: Nadine Shehata, MD MOUNT SINAI HOSPITAL
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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02042898    
Other Study ID Numbers: TRICSIII
301852 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Unity Health Toronto:
Cardiac Surgery
Transfusion