Bivalirudin Anticoagulation Dosing Protocol for Extracorporeal Membrane Oxygenation: A Retrospective Review.
Research article published in The journal of extra-corporeal technology (2018)
Abstract
Anticoagulation with unfractionated heparin during extracorporeal membrane oxygenation (ECMO) is common, but alternative agents are being evaluated for safety and efficacy. The objective of this analysis was to assess if a comprehensive bivalirudin dosing and monitoring protocol effectively guides dose adjustments and monitoring of bivalirudin in patients during ECMO. Our analysis included 11 patients who received bivalirudin during ECMO therapy and had dosing managed using our hospital derived protocol. Patients treated over a 1-year period were included in this retrospective analysis. Clinical characteristics and changes in activated partial thromboplastin time (aPTT) were evaluated from medical records to determine the efficacy of the dosing protocol. ECMO was initiated for acute respiratory distress syndrome in eight (72.7%) patients and for cardiac arrest in three (27.3%) patients. A total of 178 protocol guided dose adjustments were made during the study. Among the dose adjustments, 56 (31.5%) attained the protocol predicted aPTT level change, 96 (53.9%) of the measured aPTT changes were less than predicted, and 26 (14.6%) of the measured aPTT changes were more than predicted. On average, patients were within their defined therapeutic aPTT target range 66.3% of the time. All patients reached their designated aPTT target range within the first 24 hours of therapy. Significant bleeding was documented in eight (72.7%) patients. No clinically evident thromboembolic events were identified in vivo while cannulated. This analysis suggests that bivalirudin can be managed using a dosing protocol to provide anticoagulation therapy to patients during ECMO and can provide foundational guidance for dose adjustment and monitoring for other institutions.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Anticoagulation with unfractionated heparin during extracorporeal membrane oxygenation (ECMO) is common, but alternative agents are being evaluated for safety and efficacy. The objective of this analysis was to assess if a comprehensive bivalirudin dosing and monitoring protocol effectively guides...
Why This Matters for Hirudotherapy
This retrospective review evaluated 11 ECMO patients whose bivalirudin anticoagulation was managed via a hospital-derived dosing protocol, finding that all patients reached their target aPTT range within 24 hours, though significant bleeding occurred in 72.7% and only 31.5% of 178 dose adjustments achieved the predicted aPTT change. For ASH, this study carries genuine relevance because bivalirudin is a synthetic direct thrombin inhibitor derived from hirudin—the potent anticoagulant originally isolated from medicinal leech saliva—demonstrating how a leech-secretome derivative is being refined for critical-care anticoagulation. These real-world dosing data inform understanding of hirudin-based anticoagulant management outside traditional leech therapy. However, with only 11 patients at a single center, retrospective design, and a high bleeding rate, the protocol's safety and generalizability remain unproven, and no efficacy claims can be drawn from this small case series.
Citation
Bivalirudin Anticoagulation Dosing Protocol for Extracorporeal Membrane Oxygenation: A Retrospective Review.
Netley et al. · The journal of extra-corporeal technology, 2018
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