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Thank you for attending THSNA 2026. The virtual meeting is now closed.
Thank you for attending THSNA 2026. The virtual meeting is now closed.
Presentation Details
| The Sentinel Role of the Pathologist in Distinguishing Bivalirudin Overdosing from Contamination in Pediatric Patients on ECLS Vadim Kostousov1, Karen Bruzdoski1, Jun Teruya1, 2, 3. 1Department of Pathology & Immunology, TCH, BCM, Houston, TX, USA.2Department of Pediatrics, TCH, BCM, Houston, TX, USA.3Department of Medicine, TCH, BCM, Houston, TX, USA |
Abstract
Background: Bivalirudin, a direct thrombin inhibitor (DTI), has become the most commonly used anticoagulant in pediatric patients undergoing extracorporeal life support (ECLS) at our institution. Monitoring bivalirudin includes activated partial thromboplastin time (aPTT) and calibrated dilute thrombin time (dTT). Problem Statement: Pathologists may encounter extremely high values of bivalirudin level such as >3.0 µg/mL, raising concerns about either bivalirudin contamination from the line, which can happen due to the proximity of dual lumen of the catheter, or overdose due to a pharmacy error. Differentiating between these scenarios is critical for patient management to prevent over-anticoagulation and bleeding risk. Objective: This study aims to present coagulation test values and compare specimens contaminated with bivalirudin versus those reflecting true overdose. It also outlines a practical laboratory approach to confirm erroneous pharmacological labeling of the drug in the syringe. Methods: Prothrombin time (PT), INR, and aPTT with heparinase (HPTT, used to neutralize possible heparin contamination from the line) were extracted from the hospital database. Bivalirudin levels were measured using the STA-R Max analyzer (Diagnostica Stago, Parsippany, NJ, USA) with a calibrated 1:10 dTT assay on stored specimens, which were diluted 1:8 with normal pooled plasma (NPP). The bivalirudin concentration in the syringe was determined after a 1,000- to 10,000-fold dilution in NPP. Results: We evaluated four cases with extreme coagulation values suggestive of possible bivalirudin overdose, which required withholding the infusion and measuring bivalirudin concentration in the suspected syringe. Two cases were attributed to contamination with bivalirudin at the specimen collection, while the other two were due to erroneous pharmacy labeling. Contaminated specimens showed INR, HPTT, and bivalirudin levels similar to those of overdosed specimens (Table). Direct measurement of bivalirudin concentration in the syringe revealed levels consistent with the syringe label in contamination cases and concentrations approximately ten times higher in cases of erroneous labeling. Conclusion: Accidental overdosing can occur in specimens showing extreme coagulation values in pediatric ECLS patients anticoagulated with bivalirudin. Direct measurement of bivalirudin concentration is essential for clinical laboratories to monitor anticoagulation levels and detect potential overdose. In cases where overdose is clinically suspected, it is critical to stop the drug infusion to minimize bleeding risk. Direct measurement of bivalirudin concentration in the syringe, using an established laboratory protocol, can help confirm whether a true overdose has occurred.
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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.