American Society of Hirudotherapy

Bivalirudin or heparin for systemic anticoagulation during pediatric extracorporeal membrane oxygenation: Multicenter retrospective study

Hamzah M, Seelhammer TG, Beshish AG, Byrnes J, Yabrodi M, Szadkowski A, Lutfi R, Andrijasevic N, Hock K, Worley S, Macrae DJ (2023) · Thrombosis Research · n=225

RCT evidence detailTrial reference
GRADE LowCohort / case seriesCondition: Venous Congestion in Surgical Flaps →
Sample size of this trial compared with other Venous Congestion in Surgical Flaps trialsHuang D 20221232Valdes CA 2023313Hamzah M 2023225Iaprintsev V 202575Trigonis R 202142McMichael A 202430Engel ER 202422Sonmez E 201120Brandewie K 202410Chaudhry-Waterman N 20253
This trial (highlighted) by sample size alongside other indexed Venous Congestion in Surgical Flaps trials. Larger trials generally carry more statistical weight.

Study Profile

Design
multicenter retrospective study (children <18 years on ECMO June 2017-May 2020; UFH:bivalirudin matched 2:1 by age and ECMO type)
Sample size (n)
225
Intervention
Bivalirudin anticoagulation in pediatric ECMO (n=75)
Comparator
Unfractionated heparin anticoagulation matched 2:1 (n=150)
Primary endpoint
Bleeding events, thrombotic events, hospital mortality, neurological outcomes
Primary result
Bivalirudin associated with lower bleeding (aOR 0.23, 95% CI 0.12-0.45, p<0.001), lower thrombosis (aOR 0.48, 95% CI 0.23-0.98, p=0.045), 50% lower hospital mortality (aOR 0.50, 95% CI 0.27-0.93, p=0.028), and higher intact neurological outcomes (OR 1.99, p=0.017)
Follow-up duration
Hospital discharge
PMID
37517208

Key Findings

  • Largest contemporary pediatric ECMO bivalirudin dataset (n=225)
  • 77% relative reduction in bleeding events with bivalirudin
  • 52% relative reduction in thrombotic events
  • 50% reduction in hospital mortality
  • 2-fold higher intact neurological outcomes at discharge

Limitations

  • Retrospective design with potential selection bias
  • 2:1 matching may not eliminate confounding by indication
  • Anticoagulation targets varied across centers
  • Mortality endpoint subject to competing risks bias
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Hamzah 2023 provides the strongest contemporary observational signal favoring bivalirudin over heparin in pediatric ECMO across multiple outcomes. For ASH, this dataset demonstrates how the synthetic thrombin inhibitor pharmaceutical pathway generates aggregate evidence supporting practice change, structurally distinct from the K040187 device-leech US clinical practice. The multi-outcome signal strongly motivates definitive prospective RCT.

Related Trials

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)

Efficacy of Bivalirudin for Therapeutic Anticoagulation in COVID-19 Patients Requiring ECMO Support

Trigonis R, Smith N, Porter S, Anderson E, Jennings M, Kapoor R, Hage C, Moiz S, Garcia J, Rahman O (2021)

Bivalirudin versus heparin anticoagulation in patients receiving extracorporeal membrane oxygenation

Huang D, Guan Q, Qin J, Shan R, Wu J, Zhang C (2022)

Heparin-based versus bivalirudin-based anticoagulation in pediatric extracorporeal membrane oxygenation: A systematic review

Valdes CA, Sharaf OM, Bleiweis MS, Jacobs JP, Mumtaz M, Sharaf RM, Jeng EI, Peek GJ (2023)

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