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OpenTrials
Completed

NCT Number: NCT03318393

Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bivalirudin

Drug

Continuous infusion

Unfractionated heparin

Drug

Continuous infusion

Primary outcomes

  1. Percentage of Time Spent at Goal Anticoagulation

    Time frame: through study completion, an average of 1-2 weeks

Secondary outcomes

  1. Number of Participants With One or More Major Bleeding Events

    Time frame: through study completion, an average of 1-2 weeks

    Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding

Other outcomes

  1. Number of Blood Products Transfused

    Time frame: through study completion, an average of 1-2 weeks

    Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 23, 2017
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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