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

May 22, 2023 updated by: Wonju Severance Christian Hospital

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

Comparison nafamostat and low molecular weight heparin among dialysis patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kangwondo
      • Wonju, Kangwondo, Korea, Republic of, 26426
        • Recruiting
        • Yonsei Unviersity Wonju College of Medicin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with severe bleeding
Time Frame: 6 month
Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with dialysis circuit clot
Time Frame: 6 month
Dialysis circuit clotting due to not enough anticoagulation
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR122018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]ov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

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Conditions

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Drug Interventions

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Sponsor/Collaborators

Locations

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