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Evaluation of Serotonin Release Assay and Enzyme-Linked Immunosorbent Assay Optical Density Thresholds for Heparin-Induced Thrombocytopenia in Patients on Extracorporeal Membrane Oxygenation

Kataria, Vivek PharmD1; Moore, Leanne PharmD1; Harrison, Sarah PharmD1; Hernandez, Omar BSN2; Vaughan, Nathan MD, MPH3; Schwartz, Gary MD4

doi: 10.1097/CCM.0000000000004090
Online Clinical Investigation: PDF Only
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Objectives: Heparin-induced thrombocytopenia is a recognized concern in patients on extracorporeal life support. The purpose of this study was to evaluate the applicability of an enzyme-linked immunosorbent assay optical density threshold less than 1 to rule out heparin-induced thrombocytopenia in patients on extracorporeal membrane oxygenation.

Design: Retrospective, single-center study.

Setting: Patients were recruited from a prospectively maintained database of all patients on extracorporeal membrane oxygenation from 2012 to 2018 at a tertiary referral center.

Patients: Forty-seven patients on extracorporeal membrane oxygenation support.

Interventions: The primary objective was to evaluate the application of enzyme-linked immunosorbent assay optical density thresholds and the serotonin release assay in patients on extracorporeal membrane oxygenation. Patients were divided into two cohorts, serotonin release assay negative and serotonin release assay positive. In order to perform a sensitivity and specificity analysis of enzyme-linked immunosorbent assay optical density thresholds, heparin-induced thrombocytopenia negative was defined as an optical density less than 1.0 and heparin-induced thrombocytopenia positive as an optical density greater than or equal to 1.0.

Measurements and Main Results: Utilizing the prespecified optical density thresholds, a specificity and negative predictive value of 89% and 95% were achieved, respectively.

Conclusions: This assessment has helped to identify optical density thresholds for patients undergoing extracorporeal membrane oxygenation. Our data suggest that an optical density threshold of 1.0 may aid clinicians in objectively ruling out heparin-induced thrombocytopenia without sending a confirmatory serotonin release assay. Increasing the optical density threshold to 1.0 resulted in a high specificity and negative predictive value.

1Department of Pharmacy, Baylor University Medical Center, Dallas, TX.

2Department of Perfusion Services, Baylor University Medical Center, Dallas, TX.

3Department of Surgery, Baylor University Medical Center, Dallas, TX.

4Department of Thoracic Surgery and Lung Transplantation, Baylor University Medical Center, Dallas, TX.

Dr. Kataria is the guarantor of the content of the article, including the data and analysis. Drs. Moore, Harrison, Hernandez, Vaughan, and Schwartz served as co-investigators.

The authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: Vivek.Kataria@BSWHealth.org

Copyright © by 2019 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.