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

June 30, 2016 updated by: TOSHINOBU SATO, Japan Community Health Care Organization Sendai Hospital
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Toshinobu Sato, MD, PhD
  • Phone Number: +81-22-275-3111

Study Locations

  • Japan
    • Miyagi
      • Sendai, Miyagi, Japan, 981-8501
        • Recruiting
        • Sendai Shakaihoken Hospital
        • Contact:
          • Toshinobu Sato, MD, PhD
          • Phone Number: +81-22-275-3111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liposorber LA-15 System
Device: Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of chronic hemodialysis
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: Six months
Six months
Dose of drugs
Time Frame: Six months
Six months
Incidence of lower limb amputation
Time Frame: Six months
Six months
Incidence of gangrene
Time Frame: Six months
Six months
Incidence of multi organ failure
Time Frame: Six months
Six months
Incidence of adverse events
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Community Health Care Organization Sendai Hospital

Investigators

  • Study Director: Toshinobu Sato, MD, PhD, Japan Community Health care Organization Sendai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

November 10, 2012

First Submitted That Met QC Criteria

November 11, 2012

First Posted (ESTIMATE)

November 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 4, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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