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Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

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ClinicalTrials.gov Identifier: NCT03318393
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Complication Pediatric ALL Anticoagulants Drug: Bivalirudin Drug: Unfractionated heparin Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Active Comparator: Unfractionated heparin group
Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.
Drug: Unfractionated heparin
Continuous infusion

Experimental: Bivalirudin group
Patients randomized to this arm will receive anticoagulation with bivalirudin
Drug: Bivalirudin
Continuous infusion




Primary Outcome Measures :
  1. Percentage of time spent at goal anticoagulation [ Time Frame: through study completion, an average of 1-2 weeks ]

Secondary Outcome Measures :
  1. Incidence of 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 Outcome Measures:
  1. Number of blood products transfused [ Time Frame: through study completion, an average of 1-2 weeks ]
    Will include fresh frozen plasma, packed red blood cells, platelets and cryoprecipitate



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318393


Contacts
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Contact: Ali McMichael, MD 214-456-6222 ali.mcmichael@utsouthwestern.edu

Locations
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United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Contact: Ali McMichael, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Ali McMichael, MD UT Southwestern

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03318393     History of Changes
Other Study ID Numbers: 072017-045
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heparin
Calcium heparin
Hirudins
Bivalirudin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors