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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorWonju Severance Christian Hospital

About this trial

Comparison nafamostat and low molecular weight heparin among dialysis patients

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nafamostat Mesylate

    Drug

    Comparison effect of nafamostat and cnoxan

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: nafamostatActive comparator 1 intervention
Group B: CnoxaneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of patients with severe bleeding

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

Time frame
6 month

Secondary outcomes

1

Number of patients with dialysis circuit clot

Dialysis circuit clotting due to not enough anticoagulation

Time frame
6 month

Other outcomes

Sponsors and contacts

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