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Completed

NCT Number: NCT02478242

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Nafamostat Mesilate

Drug

nafamostat mesilate use for anticoagulation

Other names: Futhan

normal saline

Drug

Primary outcomes

  1. Number of filters used per hour

    Time frame: 24 months

Secondary outcomes

  1. Urea reduction ratio

    Time frame: 24 months

  2. Survival rate

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 23, 2015
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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