Comparison study of the Hepcon System Four and the Hemostasis Management System

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Abstract
Milwaukee Heart Surgery Associates, in affiliation with St Mary's Medical Center, were asked to be clinical investigators for a comparison study of the current Hepcon System Four (HSF) and the next generation Hemostasis Management System (HMS) manufactured by HemoTec, Inc. The HSF has been in place at St Mary's Medical Center for the past three years in a programme that performs approximately 900-1100 cardiac procedures a year. Heparin assays and high range activated clotting times (HR-ACTs) are performed routinely on all patients placed on cardiopulmonary bypass (CPB). This study will evaluate the results based upon the two systems run in tandom on a series of patients undergoing cardiac surgery with no exclusions, i.e. valve repair or replacement and myocardial revascularization. The study sets out to determine whether or not the new generation HMS has any distinct advantages over the HSF and whether it is or is not suitable for this clinical setting.

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