NCT03318393

Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

Completed Phase 4 Results posted Last updated 31 January 2023

What this trial tests

Phase 4 trial testing Bivalirudin in Extracorporeal Membrane Oxygenation Complication in 30 participants. Completed in 8 October 2021.

Timeline

25 March 2018

Primary endpoint
8 October 2021

8 October 2021

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	25 March 2018
Primary completion	8 October 2021
Estimated completion	8 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Bivalirudin (BIVALIRUDIN) — full drug profile →
• Unfractionated heparin — full drug profile →

Conditions studied

• Extracorporeal Membrane Oxygenation Complication — all drugs for Extracorporeal Membrane Oxygenation Complication →
• Pediatric ALL — all drugs for Pediatric ALL →
• Anticoagulants — all drugs for Anticoagulants →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 1 Day to 18, any sex, with Extracorporeal Membrane Oxygenation Complication or Pediatric ALL. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Time Spent at Goal Anticoagulation Primary · through study completion, an average of 1-2 weeks

Group	Value	95% CI
Unfractionated Heparin Group	0.63	0.5 – 0.82
Bivalirudin Group	0.49	0.31 – 0.54

Number of Participants With One or More Major Bleeding Events Secondary · 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

Group	Value	95% CI
Unfractionated Heparin Group	7
Bivalirudin Group	7

Number of Blood Products Transfused Secondary · through study completion, an average of 1-2 weeks

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

pRBCs

Group	Value	95% CI
Unfractionated Heparin Group	12.2	5.52 – 14.46
Bivalirudin Group	6.29	2.49 – 8.41

Platelets

Group	Value	95% CI
Unfractionated Heparin Group	13.58	2.43 – 23.94
Bivalirudin Group	4.55	0.55 – 11.51

FFP

Group	Value	95% CI
Unfractionated Heparin Group	0.16	0 – 2.84
Bivalirudin Group	1.15	0.24 – 2.79

Cryoprecipitate

Group	Value	95% CI
Unfractionated Heparin Group	0	0 – 0.19
Bivalirudin Group	0.1	0 – 1.14

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline, daily until the end of study, an average of up to 0.1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Unfractionated Heparin Group

Serious: 7/14 (50%)

Deaths: 2/14

Bivalirudin Group

Serious: 7/16 (44%)

Deaths: 3/16

Serious adverse events (1 terms)

Reaction	System	Unfractionated Heparin Group	Bivalirudin Group
Major bleeding event	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Major bleeding event.

Data from ClinicalTrials.gov NCT03318393 adverse events section.

Sponsor's own 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.

Primary aim will be to compare the efficacy of bivalirudin to unfractionated heparin.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation.
   McMichael A, Weller J, Li X, Hatton L, et al · · 2025 · cited 7× · PMID 39585174 · DOI 10.1097/pcc.0000000000003642
2. Pediatric Extracorporeal Membrane Oxygenation Anticoagulation and Monitoring: Where We Were and Where Are We Now?
   Kiskaddon AL, Sochet AA, Stock A, Ignjatovic V, et al · · 2023 · PMID 38094675 · DOI 10.5863/1551-6776-28.8.687