A-390 Implementation of the New GEM Hemochron 100 Point-of-care Coagulation System for Heparin Monitoring During Cardiopulmonary Bypass Procedures

Abstract

Abstract Background The Ohio State University Wexner Medical Center has monitored the administration of unfractionated heparin (UFH) during cardiopulmonary bypass (CPB) procedures with the activated coagulation time test, using the Hemochron Signature Elite (Elite) instrument (Werfen) with the ACT+ cartridge. An assessment was conducted to evaluate the performance of the newest Hemochron model, the GEM Hemochron 100 (Werfen), to upgrade current instruments. Methods Precision and Methods Comparison studies were conducted with nine GEM Hemochron 100 systems. Each GEM Hemochron 100 instrument was analyzed with two levels of directCHECK liquid quality control, five replicates, over four days. The Method Comparison study compared the results from one Elite system's result, against the average result reported from one to three GEM Hemochron 100 systems. This methodology was repeated in multiple groups, using different Elite and GEM Hemochron 100 systems. All tests were performed with the ACT+ assay, which is sensitive to UFH from 1–6 IU/mL. Results Precision: All nine GEM Hemochron 100 instruments yielded: Level 1 CV ≤ 9.5%, and Level 2 CV ≤ 2.5%. Method Comparison: Total datasets 66; range 94–902 seconds; estimated bias at the 300, 420, and 480 second ACT+ clinical decision points were 1.6, 3.2, 4.1 seconds respectively; correlation (r) 0.97; slope 1.01; average CV across GEM Hemochron 100 systems 6.0%. Conclusion The performance of the new GEM Hemochron 100 system demonstrated acceptable agreement compared to the Elite system during CPB, maintaining existing ACT+ procedural target times. Results of system performance were consistent with the manufacturer's package insert, as well as previously published data. Based on the clinical performance, GEM Hemochron 100 systems have been implemented into our surgical suites.