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

Abstract

Milwaukee Heart Surgery Associates in affiliation with St. Mary's Medical Center was 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 Hepcon System Four has been in place at St. Mary's Medical Center for the past three years in a program 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 comparison study will evaluate the results based upon the two systems run in tandem on a series of patients undergoing cardiac surgery with no exclusions i.e. valve repair or replacement and myocardial revascularization. The results will determine whether or not the new generation Hemostasis Management System has any distinct advantages over the Hepcon System Four and is or is not suitable for this clinical setting.