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Presentation Details
| A single-center analysis of bivalirudin infusion rates in pediatric patients requiring systemic anticoagulation for treatment or prevention of thrombosis. Jennifer Pak1, Kristin Maher2, Kiara Light1, Karyl Kanada2, Nabiha Huq Saifee3, Gavin Roach2. 1Department of Pharmacy, Seattle Children’s Hospital, Seattle, WA, USA.2Division of Hematology-Oncology, Seattle Children’s Hospital, Seattle, WA, USA.3Department of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA |
Abstract
Background Bivalirudin is an intravenous direct thrombin inhibitor more commonly used in pediatric patients on extracorporeal life support or ventricular assist devices. Currently, there is no widely accepted standardized dosing for pediatric patients on bivalirudin for other indications, such as treatment or prevention of venous thromboembolism. Historically monitored with activated partial thromboplastin time (aPTT), this parameter has limited therapeutic interpretation in patients with prolonged baseline aPTT or at higher concentrations due to a plateau effect. Dilute thrombin time (dTT) has been shown to be fivefold more likely to correlate with bivalirudin dose when compared to aPTT. Moreover, a calibrated dTT reported as drug concentration rather than time to clot can help establish consistent standards across institutions using different instruments and reagents. Objectives We sought to determine the initial bivalirudin starting rates at our institution and compare to the eventual bivalirudin infusion rates that achieved a therapeutic level of anticoagulation. Methods This was a retrospective, single-center chart review of patients aged 0-22 years on bivalirudin for treatment or prevention of thrombosis. As is our institutional standard, bivalirudin concentration was monitored using a calibrated dTT assay, with typical target range between 1-2.5 µg/mL for treatment of thrombosis. Patients on extracorporeal life support, continuous renal replacement therapy, with renal dysfunction (estimated glomerular filtration rate <60 mL/min), or for whom a bivalirudin level of less than 1 µg/mL was targeted, were excluded. Patients were stratified by age (<1 year vs ≥ 1 year). Initial and first therapeutic bivalirudin infusion rates were compared using descriptive statistics. Results Of 128 eligible patients, 93 met inclusion criteria. Sixteen included patients were <1 year old. For all patients, the overall median starting rate was 0.20 mg/kg/hr compared to median first therapeutic rate of 0.40 mg/kg/hr, and 80% (74/93) of patients needed a higher infusion rate than initially started to reach the target range for bivalirudin level. Among patients <1 year old, the median starting rate was 0.20 (IQR 0.20-0.20) mg/kg/hr, and the median first therapeutic rate was 0.55 (IQR 0.44-0.77) mg/kg/hr. For patients ≥ 1 year of age, the median starting and first therapeutic rates were 0.2 (IQR 0.20-0.20) mg/kg/hr and 0.39 (IQR 0.25-0.39) mg/kg/hr, respectively. No patients less than one year of age achieved a therapeutic bivalirudin level with the initial starting rate (see Figure 1). Conclusion This study evaluates a cohort of pediatric patients utilizing bivalirudin for treatment and prevention of thrombosis, with therapeutic anticoagulation achieved and monitored using a calibrated dTT assay. Most patients (80%) required higher infusion rates than initially started to meet or exceed the lower limit of therapeutic anticoagulation. Patients <1 year of age required higher infusion rates than older patients to achieve therapeutic levels. Based on this study we propose starting bivalirudin rates of of 0.25 mg/kg/hr and 0.45 for pediatric patients ≥ 1 year old and <1 year old, respectively.
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No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.