Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-25

Study Completion Date

2021-10-08

Brief Summary

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The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.

Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.

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Detailed Description

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The investigators will prospectively enroll 30 neonatal and pediatric ECMO patients at a single pediatric Level 1 trauma center. The patients will be randomized into two arms; one arm will receive unfractionated heparin and the other arm will receive bivalirudin. There will be 15 patients in each arm for a total of 30 patients.

The investigators hypothesize that neonatal and pediatric ECMO patients receiving bivalirudin will spend more time at goal anticoagulation and will experience less hemorrhagic and thrombotic complications when compared to patients receiving unfractionated heparin. Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin. The investigators secondary aim will be to define the incidence of hemorrhagic and thrombotic complications in patients receiving bivalirudin during ECMO.

Conditions

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Extracorporeal Membrane Oxygenation Complication Pediatric ALL Anticoagulants

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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Unfractionated heparin group

Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.

Group Type ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type DRUG

Continuous infusion

Bivalirudin group

Patients randomized to this arm will receive anticoagulation with bivalirudin

Group Type EXPERIMENTAL

Bivalirudin

Intervention Type DRUG

Continuous infusion

Interventions

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Bivalirudin

Continuous infusion

Intervention Type DRUG

Unfractionated heparin

Continuous infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 1 day to less than 18 years
* Cared for in the pediatric intensive care unit or pediatric cardiac intensive care unit
* receiving venovenous or venoarterial ECMO

Exclusion Criteria

* Patients with known or suspected heparin induced thrombocytopenia prior to consent
* Patients with hepatic failure defined as coagulopathy with elevated transaminases more than three times normal values
* Patients with plan to decannulate from ECMO within 48 hours
* Known or suspected pregnant women
* Previous enrollment in this study
* Primary language spoken that is not English or Spanish

Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No