Trial record 12 of 236 for:    Open Studies | blood transfusion

Transfusion Requirements in Cardiac Surgery III (TRICS-III)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by St. Michael's Hospital, Toronto
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT02042898
First received: January 17, 2014
Last updated: January 28, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
  • Incidence of in-hospital myocardial infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
  • Incidence of in-hospital new renal failure requiring dialysis [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
  • Incidence of in-hospital new focal neurological deficit [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
  • Length of stay in the ICU and hospital [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Duration of mechanical ventilation [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
  • Incidence of infection [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
    Infection will be defined as septic shock with positive blood cultures, pneumonia defined as roentgenographic infiltrate and two of three criteria: fever, leukocytosis, and positive sputum culture, and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement

  • Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria) [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]

    Acute kidney injury:defined by the Kidney Disease Improving Global Outcomes clinical practice guideline (KDIGO) as

    1. a 50% increase in serum creatinine within 7 days;
    2. a 26.5 µmol/L (0.3mg/dl) or greater increase within 48 hours; or
    3. urine volume less than 0.5 ml/kg/h for 6 hours

  • Incidence of gut infarction [ Time Frame: Up to hospital discharge or postoperative day 28 (whichever occurs first) ] [ Designated as safety issue: Yes ]
    Gut infarction confirmed by imaging (e.g. angiography), autopsy, or through surgical means (index hospitalization)

  • 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) ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • New onset dialysis (since incident surgery) status [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Coronary revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Health Care Utilization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3592
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 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
Genders Eligible for Study:   Both
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 the 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

Locations
Canada, Manitoba
St Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: John McVagh    204.233.8563      
Principal Investigator: Hilary Grocott, MD         
Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Charmage Crescini    416-864-6060    crescinic@smh.ca   
Principal Investigator: David Mazer, MD         
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

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02042898     History of Changes
Other Study ID Numbers: TRICSIII, 301852
Study First Received: January 17, 2014
Last Updated: January 28, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 20, 2014