Health Condition 1: Q259- Congenital malformation of great arteries, unspecified
Conditions
Interventions
Intervention1: Bivalirudin: Bivalirudin vial containing 250 mg powder will be reconstituted in 50 ml saline to yield 5 mg/ml of the drug. 25 mg bivalirudin will be added to the pump prime. The flush s
Sponsors
All India Institute of Medical science, New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: posted for elective ASO on integrated ECMO-CPB circuit.
Exclusion criteria
Exclusion criteria: Children with previous cerebrovascular accident, residual neurological deficit, intracranial neoplasm, arteriovenous malformation, history of gastrointestinal or genitourinary bleeding in the preceeding 2 weeks, acquired or congenital bleeding disorder, renal dysfunction (serum creatinine > 2 mg/dL), hepatic dysfunction (serum bilirubin > 2 mg/dL), known allergy to bivalirudin or hirudin derived drugs, refusal to receive blood transfusion, any other disease or condition that would place a child at undue risk (according to the investigatorâ??s discretion), and those presenting for emergency surgery or repeat cardiac surgery will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and efficacy of bivalirudin as an anticoagulant for neonates and infants undergoing ASO on integrated ECMO-CPB and postoperative ECMO. To determine the appropriate dosage of bivalirudin in this patient population both for open heart surgery and integrated ECMO-CPB and postoperative ECMO .Timepoint: During cardiac surgery and ICU | — |
Secondary
| Measure | Time frame |
|---|---|
| document the postoperative blood loss, transfusion requirement, major bleeding and thromboembolic events, alteration in renal function, duration of stay in the intensive care unit (ICU) and mortalityTimepoint: During cardiac surgery and ICU | — |
Countries
India
Contacts
Public ContactDr Mohanish Badge
All India Institute of Medical Science, New Drlhi
Outcome results
None listed