American Society of Hirudotherapy

Bivalirudin Monitoring in Pediatric Ventricular Assist Device and Extracorporeal Membrane Oxygenation: Analysis of Single-Center Retrospective Cohort Data 2018-2022

Engel ER, Perry T, Block M, Palumbo JS, Lorts A, Luchtman-Jones L (2024) · Pediatric Critical Care Medicine · n=22

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 retrospective laboratory validation study (Cincinnati Children's Hospital Medical Center, 2018-2022) - 115 VAD samples and 105 ECMO samples assessed
Sample size (n)
22
Intervention
Bivalirudin-calibrated dilute thrombin time (Bival dTT) assay for anticoagulation monitoring in pediatric VAD and ECMO
Comparator
Standard activated partial thromboplastin time (aPTT) assay
Primary endpoint
Correlation between Bival dTT, dTT, and aPTT vs bivalirudin plasma concentrations
Primary result
Bival dTT excellent correlation with dTT (R²=0.86-0.87) and anti-IIa (R²=0.94); aPTT correlated poorly (R²=0.004-0.1); Bival dTT validated for clinical use
Follow-up duration
VAD/ECMO support duration
PMID
38713010

Key Findings

  • aPTT correlates poorly with bivalirudin anticoagulant effect (R²=0.004-0.1)
  • Bival dTT and dTT show excellent correlation with anti-IIa (R²=0.86-0.94)
  • Provides validated alternative to aPTT for pediatric MCS monitoring
  • Single institution can validate and clinically implement
  • Opportunity for inter-institutional standardization

Limitations

  • Single-center retrospective design
  • Small patient cohort (n=22)
  • No correlation with clinical outcomes yet established
  • Therapeutic range still requires determination
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Engel 2024 addresses a critical laboratory monitoring gap for bivalirudin in pediatric mechanical circulatory support. For ASH, this work demonstrates the technical infrastructure required to safely deploy the synthetic thrombin inhibitor pharmaceutical pathway - sophisticated assays, single-institution validation, inter-institution standardization - structurally separate from the K040187 device-leech US clinical practice which requires no such monitoring infrastructure.

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)

← Back to RCT Library

This website provides educational information and does not constitute medical advice, diagnosis, or treatment recommendations. Medicinal leech therapy carries clinically meaningful risks and should be performed only by qualified clinicians under institutionally approved protocols. FDA 510(k) clearance for medicinal leeches is limited to specific indications; investigational and off-label discussions are labeled accordingly. For patient-specific guidance, consult a qualified healthcare provider.