The Effect of Nafamostat Mesilate in Prolonging Filter Patency With Patients on Continuous Renal Replacement Therapy

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Yonsei University

Status and phase

Completed
Phase 4

Conditions

Acute Kidney Injury

Treatments

Drug: Anticoagulation with nafamostat mesilate

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01761994
4-2007-0220

Details and patient eligibility

About

Continuous renal replacement therapy (CRRT) has been considered as an effective modality for renal replacement therapy in hemodynamically unstable patients within intensive care unit (ICU) except for the necessity of anticoagulation. The severity and peculiarities of ICU patients often make it equivocal to use anticoagulation. This is a prospective randomized controlled study to show the difference in filter life span and adverse event between HF1000 (nafamostat mesilate) group and M100 (heparin-free) group.

Enrollment

66 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;

    1. Platelet count < 100,000
    2. aPTT > 60 sec
    3. PT-INR > 2.0
    4. active hemorrhage
    5. surgery within 48 hours
    6. cerebral hemorrhage within 3 months or history of major bleeding
    7. septic shock or DIC.

Exclusion criteria

  • pregnancy, breast feeding, possibility of pregnancy,
  • allergy to nafamostat mesilate,
  • other conditions that physician consider unfit for candidate.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 2 patient groups

M100
Active Comparator group
Description:
heparin free CRRT group
Treatment:
Drug: Anticoagulation with nafamostat mesilate
HF1000
Experimental group
Description:
CRRT with nafamostat mesilate anticoagulation group
Treatment:
Drug: Anticoagulation with nafamostat mesilate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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