American Society of Hirudotherapy

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) · Frontiers in Medicine · n=313

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
systematic review of seven retrospective cohort studies (PubMed, Cochrane Library, Embase through October 2022)
Sample size (n)
313
Intervention
Bivalirudin anticoagulation in pediatric ECMO (n=117 pooled)
Comparator
Heparin anticoagulation in pediatric ECMO (n=196 pooled)
Primary endpoint
Bleeding events, thrombotic complications, transfusion requirements, mortality
Primary result
Bivalirudin trended toward lower bleeding, transfusion requirements, and thrombosis; no mortality difference; bivalirudin associated with lower overall costs; time to therapeutic anticoagulation variable between studies
Follow-up duration
ECMO run + hospital course
PMID
36999064

Key Findings

  • Pediatric-specific pooled analysis (n=313) of bivalirudin vs heparin
  • Trends toward lower bleeding and thrombosis with bivalirudin
  • Lower transfusion requirements with bivalirudin
  • Lower overall pharmacologic costs with bivalirudin
  • No mortality signal in either direction

Limitations

  • All 7 included studies retrospective
  • Heterogeneous anticoagulation targets across institutions
  • Small sample sizes in individual studies
  • Cannot adjust for unmeasured confounders
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Valdes 2023 provides a pediatric-specific evidence summary supporting bivalirudin as a feasible heparin alternative in children on ECMO. For ASH, the systematic review confirms the pediatric pharmaceutical pathway operates under retrospective signal-generation distinct from device-leech K040187 US clinical practice. The cost-effectiveness signal supports pharmaceutical pathway scaling under specific clinical scenarios.

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)

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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