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Clinical trial

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

ID
Name
CR122018
Description
Comparison nafamostat and low molecular weight heparin among dialysis patients
Trial arms
Trial start
2023-12-01
Estimated PCD
2023-12-31
Trial end
2024-12-31
Treatment
Nafamostat Mesylate
Comparison effect of nafamostat and cnoxan
Arms:
nafamostat
Other names:
cnoxan
Size
100
Primary endpoint
Number of patients with severe bleeding
6 month
Eligibility criteria
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-08-21

1 organization

1 product

2 indications

Organization
Wonju Severance Christian Hospital
Product
Nafamostat
Indication
Renal failure
Indication
Bleeding