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NCT05874674 Clinical Trial

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

Bleeding Clinical Trial

— Nafamostat  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05874674
Other study ID # CR122018
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date December 31, 2024

Study information
Verified date April 2023
Source Wonju Severance Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison nafamostat and low molecular weight heparin among dialysis patients

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Nafamostat Mesylate
Comparison effect of nafamostat and cnoxan

Locations
Country Name City State
Korea, Republic of Yonsei Unviersity Wonju College of Medicin Wonju Kangwondo

Sponsors (1)
Lead Sponsor Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with severe bleeding Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD) 6 month
Secondary Number of patients with dialysis circuit clot Dialysis circuit clotting due to not enough anticoagulation 6 month
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