Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation

OBJECTIVES:. Bivalirudin, an IV direct thrombin inhibitor, and unfractionated heparin (UFH) are frequently used anticoagulants in the pediatric critical care setting. An accurate, specific, point-of-care test to quantify and detect anticoagulation resistance is not currently available. This study ev...

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Main Authors: Galit H. Frydman, DVM, ScD, Barry M. Berger, MD, FCAP, Vadim Kostousov, MD, Karen Bruzdovski, BS, Dimitrios P. Papageorgiou, PhD, Amir Navaei, MD, Shiu-Ki Rocky Hui, MD, Jun Teruya, MD, DSc
Format: Article
Language:English
Published: Wolters Kluwer 2022-10-01
Series:Critical Care Explorations
Online Access:http://journals.lww.com/10.1097/CCE.0000000000000776
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author Galit H. Frydman, DVM, ScD
Barry M. Berger, MD, FCAP
Vadim Kostousov, MD
Karen Bruzdovski, BS
Dimitrios P. Papageorgiou, PhD
Amir Navaei, MD
Shiu-Ki Rocky Hui, MD
Jun Teruya, MD, DSc
author_facet Galit H. Frydman, DVM, ScD
Barry M. Berger, MD, FCAP
Vadim Kostousov, MD
Karen Bruzdovski, BS
Dimitrios P. Papageorgiou, PhD
Amir Navaei, MD
Shiu-Ki Rocky Hui, MD
Jun Teruya, MD, DSc
author_sort Galit H. Frydman, DVM, ScD
collection DOAJ
description OBJECTIVES:. Bivalirudin, an IV direct thrombin inhibitor, and unfractionated heparin (UFH) are frequently used anticoagulants in the pediatric critical care setting. An accurate, specific, point-of-care test to quantify and detect anticoagulation resistance is not currently available. This study evaluates the ability of a rapid (< 10 min), micro-volume (< 50 uL) coagulation test to detect and quantify the anticoagulation effect of bivalirudin and UFH using a functional, clot time endpoint in pediatric critical care patients. DESIGN:. Single-site retrospective laboratory sample analysis and chart review. SETTING:. A 105-bed pediatric and cardiac ICUs delivering extracorporeal membrane oxygenation. SUBJECTS:. Forty-one citrated, frozen, biobanked plasma specimens comprising 21 with bivalirudin and 20 with UFH from 15 anticoagulated pediatric patients were analyzed. Thirteen patients were on extracorporeal membrane oxygenation, one had a submassive pulmonary embolism, and one was on a left ventricular assist device. INTERVENTIONS:. None. MEASUREMENT AND MAIN RESULTS:. A Clotting Time Score (CTS) was derived on each sample. The CTS detected patients that had developed a pathologic clotting event with 100% sensitivity and 82% specificity compared with prothrombin time with 25% sensitivity/76% specificity and activated partial thromboplastin time with 0% sensitivity/0% specificity. Additionally, the CTS detected subtherapeutic anticoagulation in response to UFH in patients that were clinically determined to be UFH resistant requiring alternative anticoagulation with bivalirudin. CONCLUSIONS:. The CTS appears to be a clinically valuable indicator of coagulation status in patients treated with either UFH or bivalirudin. Results outside of the therapeutic range due to inadequate dosing or anticoagulation resistance appeared to be associated with clot formation. CTS testing may reduce the risk of anticoagulation-related complications via the rapid identification of patients at high risk for pathologic thrombotic events.
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spelling doaj.art-1cf518411f5845ae8d4a108f8c9185882022-12-22T03:43:40ZengWolters KluwerCritical Care Explorations2639-80282022-10-01410e077610.1097/CCE.0000000000000776202210000-00016Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane OxygenationGalit H. Frydman, DVM, ScD0Barry M. Berger, MD, FCAP1Vadim Kostousov, MD2Karen Bruzdovski, BS3Dimitrios P. Papageorgiou, PhD4Amir Navaei, MD5Shiu-Ki Rocky Hui, MD6Jun Teruya, MD, DSc71 Coagulo Medical Technologies, Inc., Auburndale, MA.1 Coagulo Medical Technologies, Inc., Auburndale, MA.2 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX.3 Department of Pediatrics, Baylor College of Medicine, Houston, TX.1 Coagulo Medical Technologies, Inc., Auburndale, MA.2 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX.2 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX.2 Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX.OBJECTIVES:. Bivalirudin, an IV direct thrombin inhibitor, and unfractionated heparin (UFH) are frequently used anticoagulants in the pediatric critical care setting. An accurate, specific, point-of-care test to quantify and detect anticoagulation resistance is not currently available. This study evaluates the ability of a rapid (< 10 min), micro-volume (< 50 uL) coagulation test to detect and quantify the anticoagulation effect of bivalirudin and UFH using a functional, clot time endpoint in pediatric critical care patients. DESIGN:. Single-site retrospective laboratory sample analysis and chart review. SETTING:. A 105-bed pediatric and cardiac ICUs delivering extracorporeal membrane oxygenation. SUBJECTS:. Forty-one citrated, frozen, biobanked plasma specimens comprising 21 with bivalirudin and 20 with UFH from 15 anticoagulated pediatric patients were analyzed. Thirteen patients were on extracorporeal membrane oxygenation, one had a submassive pulmonary embolism, and one was on a left ventricular assist device. INTERVENTIONS:. None. MEASUREMENT AND MAIN RESULTS:. A Clotting Time Score (CTS) was derived on each sample. The CTS detected patients that had developed a pathologic clotting event with 100% sensitivity and 82% specificity compared with prothrombin time with 25% sensitivity/76% specificity and activated partial thromboplastin time with 0% sensitivity/0% specificity. Additionally, the CTS detected subtherapeutic anticoagulation in response to UFH in patients that were clinically determined to be UFH resistant requiring alternative anticoagulation with bivalirudin. CONCLUSIONS:. The CTS appears to be a clinically valuable indicator of coagulation status in patients treated with either UFH or bivalirudin. Results outside of the therapeutic range due to inadequate dosing or anticoagulation resistance appeared to be associated with clot formation. CTS testing may reduce the risk of anticoagulation-related complications via the rapid identification of patients at high risk for pathologic thrombotic events.http://journals.lww.com/10.1097/CCE.0000000000000776
spellingShingle Galit H. Frydman, DVM, ScD
Barry M. Berger, MD, FCAP
Vadim Kostousov, MD
Karen Bruzdovski, BS
Dimitrios P. Papageorgiou, PhD
Amir Navaei, MD
Shiu-Ki Rocky Hui, MD
Jun Teruya, MD, DSc
Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
Critical Care Explorations
title Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
title_full Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
title_fullStr Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
title_full_unstemmed Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
title_short Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation
title_sort novel coagulation test detects anticoagulation resistance and is associated with thrombotic events in pediatric patients requiring extracorporeal membrane oxygenation
url http://journals.lww.com/10.1097/CCE.0000000000000776
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