Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism

Last updated: June 30, 2016
Sponsor: Japan Community Health Care Organization Sendai Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Deep Vein Thrombosis

Vascular Diseases

Claudication

Treatment

N/A

Clinical Study ID

NCT01726868
CCE-001
  • Ages 20-85
  • All Genders

Study Summary

The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients who meet all of the following criteria.

  • Patients who had cardiac catheterization or vascular surgery in the last 24 weeksbefore the time of obtaining informed consent.

  • Patients who satisfy all of the following criteria or are diagnosed as CCE by skin orrenal biopsy.

  1. Patients with progressive renal dysfunction in the course of weeks or months.

  2. Patients with skin lesions such as livedo reticularis of lower extremities orblue toe syndrome.

  3. Eosinophil count is more than 400 per microliter.

  • Patients who or patients whose legal representative understood the requirements of thestudy and signed the informed consent forms.

Exclusion

Exclusion Criteria: Patients who meet any of the following criteria will be excluded.

  • Patients with contraindication to anticoagulant (Nafamostat Mesilate).

  • Blood purification therapy is inapplicable because of severe heart failure, acutemyocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollablehypertension or hypotension.

  • Patients with body weight less than 40kg.

  • Patients with a history of allergic reaction or hypersensitivity to bloodpurification.

  • Patients who cannot stop taking ACE inhibitors.

  • Patients with any disease in which corticosteroid, statin are contraindicated.

  • Patients participated in another clinical trial or study at the time of obtaininginformed consent.

  • Patients receiving chronic hemodialysis.

  • Otherwise, patients who are judged by the investigator as being unsuitable forinclusion in the study.

Study Design

Total Participants: 35
Study Start date:
July 01, 2013
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Sendai Shakaihoken Hospital

    Sendai, Miyagi 981-8501
    Japan

    Active - Recruiting

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