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

Phase 2

• Conditions: Cholesterol Embolism
• Interventions: Device: Liposorber LA-15 System

• Registration Number: NCT01726868
• Lead Sponsor: Japan Community Health Care Organization Sendai Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-10
• Study First Submitted QC: 2012-11-11
• Study First Posted: 2012-11-15
• Study Start: 2013-07
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-30
• Last Update Posted: 2016-07-04
• Primary Completion: 2019-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients who meet all of the following criteria.

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

• Patients who satisfy all of the following criteria or are diagnosed as CCE by skin or renal 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 or blue toe syndrome.
  3. Eosinophil count is more than 400 per microliter.

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

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, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension.
• Patients with body weight less than 40kg.
• Patients with a history of allergic reaction or hypersensitivity to blood purification.
• 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 obtaining informed consent.
• Patients receiving chronic hemodialysis.
• Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liposorber LA-15 System	Liposorber LA-15 System	-

Primary Outcome Measures

Name	Time	Method
Incidence of chronic hemodialysis	Six months

Secondary Outcome Measures

Name	Time	Method
Dose of drugs	Six months
Incidence of lower limb amputation	Six months
Incidence of gangrene	Six months
Incidence of adverse events	Six months
Incidence of multi organ failure	Six months
Survival rate	Six months

Trial Locations

Locations (1)

Sendai Shakaihoken Hospital; 🇯🇵 Sendai, Miyagi, Japan