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

Cholesterol Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01726868
• Other study ID #: CCE-001
• Status: Recruiting
• Phase: Phase 2
• First received: November 10, 2012
• Last updated: June 30, 2016
• Start date: July 2013
• Est. completion date: December 2020

Study information

• Verified date: June 2016
• Source: Sendai Shakaihoken Hospital
• Contact: Toshinobu Sato, MD, PhD
• Phone: +81-22-275-3111
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholesterol Embolism
• Embolism

Intervention

Device:
• Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.

Locations

Country	Name	City	State
Japan	Sendai Shakaihoken Hospital	Sendai	Miyagi

Sponsors (1)

Lead Sponsor	Collaborator
Sendai Shakaihoken Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of chronic hemodialysis		Six months	No
Secondary	Dose of drugs		Six months	No
Secondary	Incidence of lower limb amputation		Six months	No
Secondary	Incidence of gangrene		Six months	No
Secondary	Incidence of multi organ failure		Six months	No
Secondary	Survival rate		Six months	No
Secondary	Incidence of adverse events		Six months	Yes