Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO

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.

Timeline

Start

2018-03-25

Primary completion

2021-10-08

Completion

2021-10-08

Outcome

Missed primary endpoint

paper There was no difference in the primary outcome, time spent at goal anticoagulation, for patients randomized to bivalirudin compared with those randomized to heparin. PMID 39585174 ↗

Publications

• 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.

Drugs

Indications