Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anticoagulants | — | UNRESOLVED | — |
| Extracorporeal Membrane Oxygenation Complication | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bivalirudin | Drug | — | UNRESOLVED |
| Unfractionated heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Unfractionated heparin group
- description
- Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant.
- interventionNames
- Drug: Unfractionated heparin
- type
- EXPERIMENTAL
- label
- Bivalirudin group
- description
- Patients randomized to this arm will receive anticoagulation with bivalirudin
- interventionNames
- Drug: Bivalirudin
Primary outcomes (1)
- measure
- Percentage of Time Spent at Goal Anticoagulation
- timeFrame
- through study completion, an average of 1-2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMcMichael 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 39585174