A clinical trial to study the effects of two drugs, bivalirudin and heparin in children undergoing heart surgery

Phase 4

• Conditions: Health Condition 1: null- Acyanotic congenital heart disease

• Registration Number: CTRI/2016/06/006988
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Children aged 1-12 years of either sex with acyanotic congenital heart disease undergoing open heart surgery

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 < 12 hours prior to the surgery

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BleedingTimepoint: During cardiac surgery & ICU stay

Secondary Outcome Measures

Name	Time	Method
Dose of anticoagulant required to achieve an ACT(activated clotting time) above 480 seconds <br/ ><br>Duration for which the ACT remains elevated after stopping drug infusion <br/ ><br>Duration of surgery, cardiopulmonary bypass and aortic cross clamp <br/ ><br>Adverse effects (if any) of the drug <br/ ><br>Clot formation in the CPB circuit, thromboembolic events, rhythm abnormalities <br/ ><br>Postoperative haematocrit, transfusion requirements <br/ ><br>Rate of re-exploration <br/ ><br>Postoperative renal function <br/ ><br>Timepoint: During cardiac surgery & ICU stay