Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation
McMichael A, Weller J, Li X, Hatton L, Zia A, Raman L (2024) · Pediatric Critical Care Medicine · n=30
Studienprofil
- Design
- single-center, open-label, prospective pilot randomized controlled trial (NCT03318393, US quaternary pediatric hospital, 2018-2021)
- Stichprobengröße (n)
- 30
- Intervention
- Bivalirudin direct thrombin inhibitor anticoagulation for children 0 days to <18 years on ECMO support (n=16)
- Komparator
- Unfractionated heparin anticoagulation (n=14)
- Primärer Endpunkt
- Feasibility - time at goal anticoagulation during ECMO support
- Primäres Ergebnis
- No difference in primary endpoint (time at goal anticoagulation) between groups; thrombotic complications higher in bivalirudin (6/16 with circuit changes vs 0/14 heparin, p=0.02); bivalirudin group received less packed RBC (6.3 vs 12.2 mL/kg/d, p=0.02)
- Follow-up-Dauer
- ECMO run duration
- PMID
- 39585174
Wichtigste Ergebnisse
- First prospective RCT of bivalirudin vs heparin in pediatric ECMO (NCT03318393)
- Feasibility primary endpoint achieved - similar time at goal anticoagulation
- Numerically higher thrombotic complications with bivalirudin (37.5% circuit changes vs 0%)
- Reduced packed RBC transfusion requirement with bivalirudin
- Provides justification for larger multicenter RCT
Einschränkungen
- Small pilot sample (n=30) underpowered for clinical outcomes
- Single center - generalizability limited
- Open-label design
- Not directly applicable to whole-leech hirudotherapy
- Higher circuit changes in bivalirudin arm raises questions about dosing
Klinische Implikationen
McMichael 2024 represents the first prospective randomized comparison of the synthetic hirudin-derivative bivalirudin against heparin in pediatric ECMO. For ASH, the trial anchors the pediatric pharmaceutical pathway distinct from device-leech K040187 US practice. The finding of higher circuit thrombosis with bivalirudin despite similar anticoagulation times informs caution about extrapolating adult anticoagulant protocols to pediatric mechanical circulatory support. Not directly applicable to whole-leech hirudotherapy.
Verwandte Studien
Hirulog in the treatment of unstable angina. Results of the Thrombin Inhibition in Myocardial Ischemia (TIMI) 7 trial
Fuchs J, Cannon CP (1995)
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW (2009)
Experience with pharmacologic leeching with bivalirudin for adjunct treatment of venous congestion of head and neck reconstructive flaps
Harun A, Kruer RM, Lee A, Boahene K, Byrne PJ, Richmon JD (2018)
Heparin and Bivalirudin in Percutaneous Coronary Intervention for Acute Coronary Syndromes: A Review Article
Wang G, Qi K, Li X, Zuo S, Zhang R, Zhao Y, Sun S, Zhang J, Liu X (2024)