[A clinical evaluation of the Hepcon/HMS: a new device of monitoring hemostasis management during cardiopulmonary bypass].

BACKGROUND: The "Hepcon/HMS", a small, protable console which can instantaneously measure residual whole blood heparin concentration and automatically compute the necessary dose of additional heparin during extracorporeal circulation and also compute the required dose of protamine to reverse the effect of residual heparin. METHOD: This study was performed in 32 consecutive patients undergoing primary elective cardiac operation between March and July 1996. Patients were divided randomly in two groups: control group and "Hepacon/HMS" group. Hematologic factors, total heparin dose, total protamine dose, postoperative bleeding and blood transfusion volume were compared between these two groups. RESULTS: Patients in the "Hepcon/HMS" group received significantly greater doses of heparin (p = 0.01) and lower doses of protamine (p = 0.01) compared with the control patients. CONCLUSION: By using "Hepcon/HMS", smaller amount of protamine to reverse residual heparin was achieved without no hemostatic derangement nor increase in the amount of postoperative bleeding, irrespective of the fact that the greater amount of heparin was administered during extracorporeal circulation as compared with the conventional anticoagulation protocol. It may help prevent the undesirable side effects of administering excessive amount of protamine, including depression of myocardial function, platelet dysfunction, anaphylactic reaction and catastrophic circulatory collapse.