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Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Not Applicable
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
Inclusion Criteria

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.

Exclusion Criteria

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
NameTimeMethod
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
NameTimeMethod
) 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
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