American Society of Hirudotherapy

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

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
single-center, open-label, prospective pilot randomized controlled trial (NCT03318393, US quaternary pediatric hospital, 2018-2021)
Sample size (n)
30
Intervention
Bivalirudin direct thrombin inhibitor anticoagulation for children 0 days to <18 years on ECMO support (n=16)
Comparator
Unfractionated heparin anticoagulation (n=14)
Primary endpoint
Feasibility - time at goal anticoagulation during ECMO support
Primary result
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 duration
ECMO run duration
PMID
39585174

Key Findings

  • 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

Limitations

  • 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

Clinical Implications

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.

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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)

Comparison of Bivalirudin Versus Heparin for Anticoagulation During Extracorporeal Membrane Oxygenation

Hasegawa D, Sato R, Prasitlumkum N, Nishida K, Keaton B, Acquah SO, Im Lee Y (2022)

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