American Society of Hirudotherapy

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) · Journal of Cardiothoracic and Vascular Anesthesia · n=42

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 case-control study (Indiana University Health Methodist Hospital, Indianapolis, June 2019-June 2020)
Sample size (n)
42
Intervention
Bivalirudin therapeutic anticoagulation in COVID-19 ARDS patients on venovenous ECMO (n=19)
Comparator
Bivalirudin anticoagulation in non-COVID ARDS ECMO patients (n=23)
Primary endpoint
Time at goal activated partial thromboplastin time (aPTT) and bivalirudin dose requirements
Primary result
COVID-19 ECMO patients maintained goal aPTT more consistently (86% vs 74%, p<0.01); required higher median daily bivalirudin (3.1 vs 2.4 μg/kg/min, p=0.05); no difference in bleeding or thrombosis between groups
Follow-up duration
ECMO run duration
PMID
34782234

Key Findings

  • COVID-19 ECMO required ~30% higher daily bivalirudin doses than non-COVID controls
  • Goal aPTT maintained more consistently in COVID-19 patients (86% vs 74%)
  • No difference in bleeding or thrombotic complications between cohorts
  • Suggests COVID-19 hypercoagulability alters bivalirudin dosing requirements
  • Supports bivalirudin as feasible anticoagulant in COVID-19 ECMO

Limitations

  • Retrospective single-center design
  • Small sample size (n=42) limits subgroup analysis
  • Confounded by COVID-19 era practice changes
  • Case-control rather than RCT
  • Not applicable to whole-leech hirudotherapy

Clinical Implications

Trigonis 2021 anchors COVID-19 era ECMO bivalirudin dosing precedent. For ASH, the case-control study reinforces that the pharmaceutical thrombin inhibitor pathway operates under retrospective hypothesis-generating evidence in critical care, structurally distinct from the K040187 device-leech US clinical practice for venous congestion. The COVID-19 hypercoagulability finding has no direct parallel in routine hirudotherapy applications.

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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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