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

NCT ID: NCT05874674

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-12-31

Brief Summary

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Comparison nafamostat and low molecular weight heparin among dialysis patients

Detailed Description

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Conditions

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Dialysis; Complications Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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nafamostat

Patients received dialysis through nafamostat

Group Type ACTIVE_COMPARATOR

Nafamostat Mesylate

Intervention Type DRUG

Comparison effect of nafamostat and cnoxan

Cnoxane

Patients received dialysis through cnoxan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nafamostat Mesylate

Comparison effect of nafamostat and cnoxan

Intervention Type DRUG

Other Intervention Names

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cnoxan

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wonju Severance Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei Unviersity Wonju College of Medicin

Wŏnju, Kangwondo, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Jun Young Lee

Role: primary

820337410935

References

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Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

Reference Type DERIVED
PMID: 38189593 (View on PubMed)

Other Identifiers

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CR122018

Identifier Type: -

Identifier Source: org_study_id

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