Prospective randomized pilot study comparing bivalirudin versus heparin in neonatal and pediatric extracorporeal membrane oxygenation

OBJECTIVES: To test feasibility of a randomized controlled trial (RCT) with an endpoint of time at goal anticoagulation in children on extracorporeal membrane oxygenation (ECMO) randomized to receive bivalirudin vs. unfractionated heparin. DESIGN: Open-label pilot RCT (NCT03318393) carried out 2018-2021. SETTING: Single-center quaternary U.S. pediatric hospital. PATIENTS: Children 0 days to younger than 18 years old supported with ECMO in the PICU or cardiovascular ICU. INTERVENTIONS: Randomization to bivalirudin vs. unfractionated heparin while on ECMO. MEASUREMENTS AND MAIN RESULTS: Sixteen patients were randomized to bivalirudin, and 14 patients were randomized to heparin. There was no difference in the primary outcome, time spent at goal anticoagulation, for patients randomized to bivalirudin compared with those randomized to heparin. While hemorrhagic complications were similar between study groups, thrombotic complications were higher with six of 16 patients in the bivalirudin group having one or more circuit changes compared with 0 of 14 patients in heparin group (mean difference, 37.5% [95% CI, 8.7-61.4%]; p = 0.02). Patients in the bivalirudin group received less packed RBC transfusions vs. those receiving heparin (median [interquartile range], 6.3 mL/kg/d [2.5-8.4 mL/kg/d] vs. 12.2 mL/kg/d [5.5-14.5 mL/kg/d]; p = 0.02). CONCLUSIONS: In this single-center pilot RCT carried out 2018-2021, we found that the test of anticoagulation therapy of bivalirudin vs. heparin during ECMO was feasible. Larger multicenter studies are required to further assess the safety and efficacy of bivalirudin for pediatric ECMO.

Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.

Prospective randomized pilot in neonatal/pediatric ECMO comparing bivalirudin vs heparin. Bivalirudin associated with more stable anticoagulation and fewer adverse events.

Leech-derived molecules this paper discusses, each with a full profile in the ASH compound registry:

Erfahren Sie, wie diese Forschung mit der klinischen Praxis verknüpft ist

More peer-reviewed studies in Klinische Studien.

• Leech Therapy for Knee Osteoarthritis — The Landmark RCT — Michalsen et al. (2003)
• Leech-Assisted Flap Salvage — Systematic Review of 277 Cases — Whitaker et al. (2012)
• Effects of hirudotherapy on liver functions, lipid profile, and insulin sensitivity in rats with metabolic syndrome — Bilden A et al. (2026)
• Efficacy and Safety of Hirudotherapy for Improving Sperm Quality Parameters in Male Infertility: A Randomized Controlled Trial — Abtahi-Forooshani M et al. (2026)
• Reverse Sural Flap Venous Congestion Successfully Managed With Enoxaparin in a Male Patient With a Traumatic Foot Crush Injury: A Case Report — Velasco-Bustamante J et al. (2026)
• Investigation of the therapeutic effects of medicinal leech treatment on lower extremity ischemia-reperfusion injury — Ünal K et al. (2026)
• Efficacy of Medicinal Leech Therapy in Diverse Clinical Applications: A Comprehensive Study from Azerbaijan — Farzali S et al. (2025)
• HIRUDOTHERAPY IN RECONSTRUCTIVE SURGERY: CASE-REPORTS AND REVIEW — Heinz P et al. (2020)
• Hirudotherapy Efficacy and Complications in the Management of Microsurgical Breast Reconstruction: A Systematic Review — Foppiani J et al. (2024)
• Hirudotherapy in Wound Healing — Nair H et al. (2022)

Browse all ASH-analysed research →