NCT03318393

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 25, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2021

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 31, 2023

Completed
Last Updated

January 31, 2023

Status Verified

December 1, 2022

Enrollment Period

3.5 years

First QC Date

October 4, 2017

Results QC Date

October 11, 2022

Last Update Submit

January 28, 2023

Conditions

Extracorporeal Membrane Oxygenation ComplicationPediatric ALLAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • Percentage of Time Spent at Goal Anticoagulation

    through study completion, an average of 1-2 weeks

Secondary Outcomes (1)

  • Number of Participants With One or More Major Bleeding Events

    through study completion, an average of 1-2 weeks

Other Outcomes (1)

  • Number of Blood Products Transfused

    through study completion, an average of 1-2 weeks

Study Arms (2)

Unfractionated heparin group

ACTIVE COMPARATOR

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

Drug: Unfractionated heparin

Bivalirudin group

EXPERIMENTAL

Patients randomized to this arm will receive anticoagulation with bivalirudin

Drug: Bivalirudin

Interventions

BivalirudinDRUG

Continuous infusion

Bivalirudin group
Unfractionated heparinDRUG

Continuous infusion

Unfractionated heparin group

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2025 Jan 1;26(1):e86-e94. doi: 10.1097/PCC.0000000000003642. Epub 2024 Nov 25.

    PMID: 39585174DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

bivalirudinHeparin

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Lakshmi Raman
Organization
UT Southwestern Medical Center
lakshmi.raman@utsw.edu
214-456-6222

Study Officials

  • Ali McMichael, MD

    UT Southwestern

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 23, 2017

Study Start

March 25, 2018

Primary Completion

October 8, 2021

Study Completion

October 8, 2021

Last Updated

January 31, 2023

Results First Posted

January 31, 2023

Record last verified: 2022-12

Locations

US(1)