Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
- Conditions
- Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery
- Registration Number
- CTRI/2023/01/048759
- Lead Sponsor
- Dr David Mazer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. >=18 and <=65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of
6 or more.
1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion of a
ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization
for women of childbearing potential)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is primary composite endpoint of all-cause mortality, myocardial infarction <br/ ><br>defined in accordance with the 4th Universal Definition of Myocardial Infarction, new-onset renal <br/ ><br>failure with dialysis, or new focal neurological deficit (stroke) lasting more than 24 hours <br/ ><br>confirmed by clinical and/or computed tomographic scan, occurring within 6 months of the initial <br/ ><br>surgeryTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method ) Incidence of each individual component of the primary outcome: all-cause mortality, <br/ ><br>myocardial infarction, new onset renal failure requiring dialysis, and new focal <br/ ><br>neurological deficit (stroke) within 6 months <br/ ><br>2) Composite and individual all-cause mortality, myocardial infarction, new onset renal <br/ ><br>failure requiring dialysis, and new focal neurological deficit (stroke) with index <br/ ><br>hospitalization or after 28 days postoperatively, whichever comes first <br/ ><br>3) Length of stay in the Intensive Care Unit (ICU) and hospital (index hospitalization) <br/ ><br>4) Prolonged low output state defined as the need for two or more inotropes for 24 hours or <br/ ><br>more, intra-aortic balloon pump or ventricular assist device postoperatively (index <br/ ><br>hospitalization) <br/ ><br>5) Duration of mechanical ventilation (index hospitalization)Timepoint: 6 Months