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

Sponsor
Wonju Severance Christian Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05874674
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison nafamostat and low molecular weight heparin among dialysis patients

Condition or Disease Intervention/Treatment Phase
  • Drug: Nafamostat Mesylate
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Diathesis Undergoing Hemodialysis: A Pilot Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: nafamostat

Patients received dialysis through nafamostat

Drug: Nafamostat Mesylate
Comparison effect of nafamostat and cnoxan
Other Names:
  • cnoxan

    		•
    No Intervention: Cnoxane

    Patients received dialysis through cnoxan

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with severe bleeding [6 month]

      Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)

    Secondary Outcome Measures

    1. Number of patients with dialysis circuit clot [6 month]

      Dialysis circuit clotting due to not enough anticoagulation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei Unviersity Wonju College of Medicin Wonju Kangwondo Korea, Republic of 26426

    Sponsors and Collaborators

    • Wonju Severance Christian Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wonju Severance Christian Hospital
    ClinicalTrials.gov Identifier:
    NCT05874674
    Other Study ID Numbers:
    • CR122018
    First Posted:
    May 25, 2023
    Last Update Posted:
    May 25, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wonju Severance Christian Hospital
    dialysis
    bleeding
    nafamostat
    heaprin
    Additional relevant MeSH terms:
    Hemorrhage
    Nafamostat

    Study Results

    No Results Posted as of May 25, 2023