A Multi-Center Phase III Clinical Trial to Assess the Influence to Bleeding and Anticoagulant Effect of Nafamostat Mesilate (Futhan) in Hemodialysis Patients with High Bleeding-Risk / 대한신장학회잡지

ABSTRACT

BACKGROUND: Routine hemodialysis is performed with systemic anticoagulation, usually with heparin, to prevent thrombosis in the extracorporeal blood circuit. However, systemic anticoagulation can produce hemorrhagic complications in patients at high risk of bleeding. To minimize the risk of bleeding, a number of alternative regimens has been proposed, however, each of those methods has its own limitations and complication. METHODS: 58 hemodialysis patients at risk for bleeding due to previous surgery or hemorrhagic complication were treated with Futhan as regional anticoagulant and compared with that of low-dose heparin anticoagulation. There were 29 (50%) postoperative cases and 29 (50%) cases of hemorrhage from various sites. RESULTS: The exacerbation of bleeding by hemodialysis was noted in only 4% in heparin treated group and none in Futhan group. Clotting times at site A (intracorporeal circulation) were not prolonged with Futhan, whereas those of heparin were prolonged slightly, which is not statistically significant. Degrees of residual blood in the dialyzer and blood clottings in the venous drip-chamber were less in Futhan than in heparin group. Adverse reactions related to Futhan therapy were minor and the incidence of adverse reactions was comparable in both groups. CONCLUSION: Futhan is a safe and effective regional anticoagulant for hemodialysis especially for patients with high bleeding risk.