The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborators: SK Chemicals Co., Ltd.; SK Chemicals Co.,Ltd.
• Treatments: Nafamostat

Criteria

Inclusion Criteria:

• patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;

1. Platelet count < 100,000

2. aPTT > 60 sec

3. PT-INR > 2.0

4. active hemorrhage

5. surgery within 48 hours

6. cerebral hemorrhage within 3 months or history of major bleeding

7. septic shock or DIC.

Exclusion Criteria:

• pregnancy, breast feeding, possibility of pregnancy,

• allergy to nafamostat mesilate,

• other conditions that physician consider unfit for candidate.