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

Japan Community Health Care Organization Sendai Hospital

Status and phase: Unknown; Phase 2

Conditions: Cholesterol Embolism

Treatments: Device: Liposorber LA-15 System

Study type: Interventional

Funder types: Other

Identifiers

NCT01726868

CCE-001

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

Liposorber LA-15 System

Experimental group

Treatment:

Device: Liposorber LA-15 System