Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Extracorporeal Membrane Oxygenation Complication; Anticoagulants
• Intervention / Treatment: Drug: Unfractionated heparin; Drug: Bivalirudin

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of time spent at goal anticoagulation	through study completion, an average of 1-2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major bleeding events	Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding	through study completion, an average of 1-2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of blood products transfused	Will include fresh frozen plasma, packed red blood cells, platelets and cryoprecipitate	through study completion, an average of 1-2 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Ali McMichael, MD, UT Southwestern

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2018
• Primary Completion (Actual): October 8, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Bivalirudin; Calcium heparin
• Other Study ID Numbers: 072017-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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