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

Kyungpook National University

Status and phase: Completed; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Normal saline; Drug: Nafamostat mesilate

Study type: Interventional

Funder types: Other

Identifiers

NCT02478242

KNUH_08-0023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Nafamostat mesilate group

Active Comparator group

Description:

Nafamostat mesilate was used for maintenance anticoagulation during continuous renal replacement therapy.

Treatment:

Drug: Nafamostat mesilate

No anticoagulation group

Placebo Comparator group

Description:

Normal saline was used for maintenance anticoagulation during continuous renal replacement therapy.

Treatment:

Drug: Normal saline