Bivalirudin vs Heparin in ECMO Patients

Johns Hopkins University

Status and phase: Withdrawn; Phase 1

Conditions: Extracorporeal Membrane Oxygenation Complication

Treatments: Drug: Bivalirudin Injection [Angiomax]; Drug: Heparin Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT03707418

IRB00176475

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO

Exclusion criteria

• Patient or surrogate decision makers cannot provide informed consent.
• Patients who have intolerance to either heparin or bivalirudin
• Patients who received any form of thrombolytic therapy within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Bivalirudin Injection (Angiomax)

Active Comparator group

Description:

This arm will receive intravenous Bivalirudin for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first

Treatment:

Drug: Bivalirudin Injection [Angiomax]

Heparin Sodium

Active Comparator group

Description:

This arm will receive intravenous Heparin Sodium for ECMO anticoagulation for the extent of ECMO support or 7 days whichever comes first

Treatment:

Drug: Heparin Sodium