Bivalirudin vs Heparin in ECMO Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-06-30

Brief Summary

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

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Detailed Description

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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

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Extracorporeal Membrane Oxygenation Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bivalirudin Injection (Angiomax)

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

Group Type ACTIVE_COMPARATOR

Bivalirudin Injection [Angiomax]

Intervention Type DRUG

Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Heparin Sodium

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

Group Type ACTIVE_COMPARATOR

Heparin Sodium

Intervention Type DRUG

Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels

Interventions

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Heparin Sodium

Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels

Intervention Type DRUG

Bivalirudin Injection [Angiomax]

Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No