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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
5,028
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
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
Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)
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)
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San Francisco VA Medical Center
San Francisco, California, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
Maine Medical Center
Portland, Maine, United States
Montefiore Medical Center
The Bronx, New York, United States
Durham Veterans Affairs Medical Center
Durham, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
...and 64 more locations
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)