Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03318393

Collaborator

(none)

Enrollment

Location

Arms

42.5

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 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 Design

Study Type:

Interventional

Actual 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 :

Mar 25, 2018

Actual Primary Completion Date :

Oct 8, 2021

Actual Study Completion Date :

Oct 8, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of time spent at goal anticoagulation [through study completion, an average of 1-2 weeks]

Secondary Outcome Measures

Incidence of major bleeding events [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

Number of blood products transfused [through study completion, an average of 1-2 weeks]
Will include fresh frozen plasma, packed red blood cells, platelets and cryoprecipitate

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Medical Center	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Ali McMichael, MD, UT Southwestern

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali McMichael, ASSISTANT PROFESSOR, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT03318393

Other Study ID Numbers:

072017-045

First Posted:

Oct 23, 2017

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Heparin

Calcium heparin

Bivalirudin

Study Results

No Results Posted as of Mar 2, 2022