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

Primary Purpose

Dialysis; Complications, Bleeding

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Nafamostat Mesylate
Sponsored by
Wonju Severance Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dialysis; Complications focused on measuring dialysis, bleeding, nafamostat, heaprin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Yonsei Unviersity Wonju College of Medicin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

nafamostat

Cnoxane

Arm Description

Patients received dialysis through nafamostat

Patients received dialysis through cnoxan

Outcomes

Primary Outcome Measures

Number of patients with severe bleeding
Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)

Secondary Outcome Measures

Number of patients with dialysis circuit clot
Dialysis circuit clotting due to not enough anticoagulation

Full Information

First Posted
April 18, 2023
Last Updated
August 17, 2023
Sponsor
Wonju Severance Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05874674
Brief Title
The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Undergoing Hemodialysis: A Pilot Study
Acronym
Nafamostat
Official Title
The Safety of Nafamostat Mesylate for Patients With High Risk Bleeding Diathesis Undergoing Hemodialysis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wonju Severance Christian Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparison nafamostat and low molecular weight heparin among dialysis patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis; Complications, Bleeding
Keywords
dialysis, bleeding, nafamostat, heaprin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nafamostat
Arm Type
Active Comparator
Arm Description
Patients received dialysis through nafamostat
Arm Title
Cnoxane
Arm Type
No Intervention
Arm Description
Patients received dialysis through cnoxan
Intervention Type
Drug
Intervention Name(s)
Nafamostat Mesylate
Other Intervention Name(s)
cnoxan
Intervention Description
Comparison effect of nafamostat and cnoxan
Primary Outcome Measure Information:
Title
Number of patients with severe bleeding
Description
Brain hemorrhage (on brain CT), gastrointestinal bleeding (on EGD)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Number of patients with dialysis circuit clot
Description
Dialysis circuit clotting due to not enough anticoagulation
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Yonsei Unviersity Wonju College of Medicin
City
Wonju
State/Province
Kangwondo
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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