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

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Hematology

Background:

• St. Mary's Medical Center utilizes the Hepcon System Four (HSF) for cardiac procedures.
• The HSF has been used for three years, supporting 900-1100 cardiac procedures annually.
• Routine monitoring includes heparin assays and high range activated clotting times (HR-ACTs) during cardiopulmonary bypass (CPB).

Purpose of the Study:

• To clinically investigate and compare the existing Hepcon System Four (HSF) with the next-generation Hemostasis Management System (HMS).
• To evaluate the suitability and potential advantages of the new HMS in a clinical cardiac surgery setting.

Main Methods:

• A comparative study involving clinical investigators from Milwaukee Heart Surgery Associates.
• Evaluation of both HSF and the new HMS systems run in tandem.
• Inclusion of all consecutive cardiac surgery patients, including valve repair/replacement and myocardial revascularization, with no exclusions.

Main Results:

• Data collection and analysis are ongoing.
• The study aims to identify distinct advantages of the new HMS over the HSF.
• Assessment of the new HMS's clinical applicability and performance.

Conclusions:

• The study will determine if the new Hemostasis Management System (HMS) offers significant benefits over the current Hepcon System Four (HSF).
• Findings will inform the suitability of the HMS for routine use in cardiac surgery at St. Mary's Medical Center.