Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery (TRICS IV)

Not Applicable

Recruitment & Eligibility

Inclusion Criteria

>= 18 and <= 65 years of age

Planned cardiac surgery using cardiopulmonary bypass

Informed consent obtained

Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more: www.euroscore.org/calcold.html)

Exclusion Criteria

Patients who refuse participation

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)

Primary Outcome Measures

Name	Time	Method
Composite score of any one of the following events occurring 6 <br/ ><br>months after cardiac surgery: (1) all-cause mortality; (2) myocardial <br/ ><br>infarction; (3) new onset renal failure requiring dialysis; or (4) new <br/ ><br>focal neurological deficit (stroke)Timepoint: 6 month

Secondary Outcome Measures

Name	Time	Method
Allcause <br/ ><br>mortality, myocardial infarction, new onset renal failure <br/ ><br>requiring dialysis, and new focal neurological deficit (stroke) within <br/ ><br>6 months <br/ ><br>Composite and individual all-cause mortality, myocardial infarction, <br/ ><br>new onset renal failure requiring dialysis, and new focal neurological <br/ ><br>deficit (stroke) with index hospitalization or after 28 days <br/ ><br>postoperatively, whichever comes first <br/ ><br>Length of stay in the Intensive Care Unit (ICU) and hospital (index <br/ ><br>hospitalization) <br/ ><br>Prolonged low output state defined as the need for two or more <br/ ><br>inotropes for 24 hours or more, intra-aortic balloon pump or <br/ ><br>ventricular assist device postoperatively (index hospitalization) <br/ ><br>Duration of mechanical ventilation (index hospitalization) <br/ ><br>Infection: Pneunomia, Delirium, Acute Kidney Injury, Gut infection, Seizures, Encephalopathy, Hospital visitsTimepoint: 6 months