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

NCT01726868 | Unknown Phase 2 DMC

• 1 other identifier: CCE-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholesterol Embolism

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic hemodialysis

  Six months

Secondary Outcomes (6)

• Dose of drugs

  Six months

• Incidence of lower limb amputation

  Six months

• Incidence of gangrene

  Six months

• Incidence of multi organ failure

  Six months

• Survival rate

  Six months

Study Arms (1)

Liposorber LA-15 System

EXPERIMENTAL

Device: Liposorber LA-15 System

Interventions

Liposorber LA-15 System DEVICE

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

Liposorber LA-15 System

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients with progressive renal dysfunction in the course of weeks or months.
• Patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Japan Community Health Care Organization Sendai Hospital: lead

Study Sites (1)

Sendai Shakaihoken Hospital

Sendai, Miyagi, 981-8501, Japan

RECRUITING

Related Publications (1)

• Ishiyama K, Sato T. Efficacy of LDL apheresis for the treatment of cholesterol crystal embolism: A prospective, controlled study. Ther Apher Dial. 2022 Apr;26(2):456-464. doi: 10.1111/1744-9987.13706. Epub 2021 Jul 11.

  PMID: 34216189 DERIVED

MeSH Terms

Conditions

Embolism, Cholesterol

Condition Hierarchy (Ancestors)

Embolism, Fat; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Toshinobu Sato, MD, PhD

  Japan Community Health Care Organization Sendai Hospital

  STUDY DIRECTOR

Central Study Contacts

Toshinobu Sato, MD, PhD

CONTACT

+81-22-275-3111

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 10, 2012
• First Posted: November 15, 2012
• Study Start: July 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: July 4, 2016

Record last verified: 2016-06

Locations

JP (1)