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.
Brief Title
Transfusion Requirements in Cardiac Surgery III
Categories
Completion Date
Completion Date Type
Actual
Conditions
Disorder; Heart, Functional, Postoperative, Cardiac Surgery
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Cardiac Surgery
Transfusion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02042898
Org Class
Other
Org Full Name
Unity Health Toronto
Org Study Id
TRICSIII
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery
Primary Outcomes
Outcome Description
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
Outcome Measure
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
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Secondary Ids
Secondary Id
301852
Secondary Outcomes
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of in-hospital all-cause mortality
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of in-hospital myocardial infarction
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of in-hospital new renal failure requiring dialysis
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of in-hospital new focal neurological deficit
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Length of stay in the ICU and hospital
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
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
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Duration of mechanical ventilation
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of infection
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of gut infarction
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
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)
Outcome Time Frame
6 months
Outcome Measure
Death
Outcome Time Frame
6 months
Outcome Measure
New onset dialysis (since incident surgery) status
Outcome Time Frame
6 months
Outcome Measure
Stroke
Outcome Time Frame
6 months
Outcome Measure
Coronary revascularization
Outcome Time Frame
6 months
Outcome Measure
Myocardial infarction
Outcome Time Frame
6 months
Outcome Measure
Health Care Utilization
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Renal function, based on changes in postoperative serum creatinine
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of Seizures
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of Encephalopathy
Outcome Time Frame
Up to hospital discharge or postoperative day 28 (whichever occurs first)
Outcome Measure
Incidence of Delirium
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Leff
Investigator Email
jleff@montefiore.org
Investigator Phone