The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Undergoing Hemodialysis: A Pilot Study

Not Applicable

Recruiting

• Conditions: Bleeding; Dialysis; Complications
• Interventions: Drug: Nafamostat Mesylate

• Registration Number: NCT05874674
• Lead Sponsor: Wonju Severance Christian Hospital

Brief Summary

Comparison nafamostat and low molecular weight heparin among dialysis patients

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-25
• Study Start: 2023-12-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-28
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• platelet below 10k PTT above 60 second INR above 20 patient with bleeding (epistaxis, orbital bleeding, hematuria) recent brain hemorrhage (within 6 months) receiving anticoagulant therapy (coumadin or NOAC) dual antiplatelet agent users received major surgery within one month

Exclusion Criteria

• cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nafamostat	Nafamostat Mesylate	Patients received dialysis through nafamostat

Primary Outcome Measures

Name	Time	Method
Number of patients with severe bleeding	6 month	Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)

Secondary Outcome Measures

Name	Time	Method
Number of patients with dialysis circuit clot	6 month	Dialysis circuit clotting due to not enough anticoagulation

Trial Locations

Locations (1)

Yonsei Unviersity Wonju College of Medicin; 🇰🇷 Wonju, Kangwondo, Korea, Republic of