NCT03707418

Bivalirudin vs Heparin in ECMO Patients

A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

Detailed description

This open label randomized study will compare the clinical outcomes of patients on ECMO who are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient time to randomize these frequently emergent patients. Consent for the study will be obtained from a legally authorized representative Prior to starting a continuous infusion of maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of cross-overs between the two research arms, circuit failures, decannulation, deaths and discharges from hospital.

Conditions

• Extracorporeal Membrane Oxygenation Complication

Interventions

Type	Name	Description
DRUG	Heparin Sodium	Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels
DRUG	Bivalirudin Injection [Angiomax]	Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2018-10-16
• Last updated: 2021-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study