PMID- 36311559 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230105 IS - 2639-8028 (Electronic) IS - 2639-8028 (Linking) VI - 4 IP - 10 DP - 2022 Oct TI - Novel Coagulation Test Detects Anticoagulation Resistance and Is Associated With Thrombotic Events in Pediatric Patients Requiring Extracorporeal Membrane Oxygenation. PG - e0776 LID - 10.1097/CCE.0000000000000776 [doi] LID - e0776 AB - 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. CI - Copyright (c) 2022 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine. FAU - Frydman, Galit H AU - Frydman GH AD - Coagulo Medical Technologies, Inc., Auburndale, MA. FAU - Berger, Barry M AU - Berger BM AD - Coagulo Medical Technologies, Inc., Auburndale, MA. FAU - Kostousov, Vadim AU - Kostousov V AD - Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX. AD - Department of Pediatrics, Baylor College of Medicine, Houston, TX. FAU - Bruzdovski, Karen AU - Bruzdovski K AD - Department of Pediatrics, Baylor College of Medicine, Houston, TX. FAU - Papageorgiou, Dimitrios P AU - Papageorgiou DP AD - Coagulo Medical Technologies, Inc., Auburndale, MA. FAU - Navaei, Amir AU - Navaei A AD - Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX. AD - Department of Pediatrics, Baylor College of Medicine, Houston, TX. FAU - Hui, Shiu-Ki Rocky AU - Hui SR AD - Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX. AD - Department of Pediatrics, Baylor College of Medicine, Houston, TX. FAU - Teruya, Jun AU - Teruya J AD - Department of Pathology & Immunology, Baylor College of Medicine, Houston, TX. AD - Department of Pediatrics, Baylor College of Medicine, Houston, TX. AD - Department of Anesthesiology, Baylor College of Medicine, Houston, TX. AD - Department of Medicine, Baylor College of Medicine, Houston, TX. LA - eng PT - Journal Article DEP - 20221025 PL - United States TA - Crit Care Explor JT - Critical care explorations JID - 101746347 EIN - Crit Care Explor. 2022 Dec 28;5(1):e0836. PMID: 36600783 PMC - PMC9605743 OTO - NOTNLM OT - ECMO OT - VAD OT - anticoagulation OT - bivalirudin OT - heparin OT - thrombosis COIS- Dr. Frydman is the Chief Scientific Officer of Coagulo Medical Technologies. Dr. Berger is the Chief Medical Officer of Coagulo Medical Technologies. Dr. Papageorgiou is a scientist at Coagulo Medical Technologies. Dr. Teruya is a consultant of Agios and Apelo and a board member of Data Safety Monitoring of Evaheart. The remaining authors have disclosed that they do not have any potential conflicts of interest. EDAT- 2022/11/01 06:00 MHDA- 2022/11/01 06:01 PMCR- 2022/10/25 CRDT- 2022/10/31 04:23 PHST- 2022/10/31 04:23 [entrez] PHST- 2022/11/01 06:00 [pubmed] PHST- 2022/11/01 06:01 [medline] PHST- 2022/10/25 00:00 [pmc-release] AID - 10.1097/CCE.0000000000000776 [doi] PST - epublish SO - Crit Care Explor. 2022 Oct 25;4(10):e0776. doi: 10.1097/CCE.0000000000000776. eCollection 2022 Oct.