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Trial to Assess the Efficacy and Safety of Nafamostat Mesilate During Continuous Renal Replacement Therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02478242
Enrollment
60
Registered
2015-06-23
Start date
2010-07-31
Completion date
2015-06-30
Last updated
2015-06-23

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

Conditions

Acute Kidney Injury

Brief summary

Randomized study to evaluate the efficacy and safety of nafamostat mesilate use during continuous renal replacement therapy in acute kidney injury patients at a high risk of bleeding.

Detailed description

Patients were randomly assigned to the nafamostat mesilate (NM) group or the no anticoagulant (NA) group. In patients assigned to the NM group, NM (20mg/h) was used for maintenance anticoagulation. Whereas, in patients assigned to the NA group, normal saline (2mL/h) was infused for continuous renal replacement therapy.

Interventions

nafamostat mesilate use for anticoagulation

DRUGNormal saline

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who were admitted to the intensive care unit and required CRRT 1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage, 2. activated partial thromboplastin time \> 60 s, 3. prothrombin time-international normalized ratio \> 2.0, 4. thrombocytopenia (\<100,000/µL), and 5. surgery within 48 h before CRRT.

Exclusion criteria

* Pregnant or possibly pregnant women * Patients who were allergic to nafamostat mesilate * Patients who were hypercoagulable

Design outcomes

Primary

MeasureTime frame
Number of filters used per hour24 months

Secondary

MeasureTime frame
Urea reduction ratio24 months
Survival rate24 months

Outcome results

None listed

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