Health Condition 1: null- Acyanotic congenital heart disease
Conditions
Interventions
Intervention1: Bivalirudin: Bivalirudin vial containing 250 mg powder will be reconstituted in 20 ml saline to yield 12.5 mg/ml of the drug. 50 mg bivalirudin will be added to the pump prime. The flus
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 1-12 years of either sex with acyanotic congenital heart disease undergoing open heart surgery
Exclusion criteria
Exclusion criteria: Emergency surgery Previous cardiac surgery Multiple ventricular septal defects Cyanotic congenital heart disease Cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit. Intracranial neoplasm, arteriovenous malformation, or aneurysm. History of gastrointestinal or genitourinary bleeding in the previous 2 weeks Acquired or congenital bleeding disorder Patients with renal dysfunction (serum creatinine > 2 mg/dL) or undergoing renal dialysis Received warfarin with INR >1.5 immediately prior to the procedure or UFH less than 1 hour prior or low molecular weight heparin Known allergy to bivalirudin or hirudin derived drugs, or known sensitivity to any component of the product. Refusal to undergo blood transfusion should it become necessary. Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial or inability to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BleedingTimepoint: During cardiac surgery & ICU stay | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose of anticoagulant required to achieve an ACT(activated clotting time) above 480 seconds Duration for which the ACT remains elevated after stopping drug infusion Duration of surgery, cardiopulmonary bypass and aortic cross clamp Adverse effects (if any) of the drug Clot formation in the CPB circuit, thromboembolic events, rhythm abnormalities Postoperative haematocrit, transfusion requirements Rate of re-exploration Postoperative renal function Timepoint: During cardiac surgery & ICU stay | — |
Countries
India
Contacts
Public ContactDr Suruchi Hasija
All India Institute of Medical Sciences
Outcome results
None listed