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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05874674

Acronym

Nafamostat

Enrollment

100

Registered

2023-05-25

Start date

2023-12-01

Completion date

2026-12-31

Last updated

2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis; Complications, Bleeding

Keywords

dialysis, bleeding, nafamostat, heaprin

Brief summary

Comparison nafamostat and low molecular weight heparin among dialysis patients

Interventions

DRUGNafamostat Mesylate

Comparison effect of nafamostat and cnoxan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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)

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026