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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Sendai Shakaihoken Hospital
Sponsor:
Information provided by (Responsible Party):
TOSHINOBU SATO, Sendai Shakaihoken Hospital
ClinicalTrials.gov Identifier:
NCT01726868
First received: November 10, 2012
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Cholesterol Embolism
Device: Liposorber LA-15 System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism

Resource links provided by NLM:


Further study details as provided by Sendai Shakaihoken Hospital:

Primary Outcome Measures:
  • Incidence of chronic hemodialysis [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dose of drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Incidence of lower limb amputation [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Incidence of gangrene [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Incidence of multi organ failure [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Survival rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 35
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liposorber LA-15 System Device: Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726868

Contacts
Contact: Toshinobu Sato, MD, PhD +81-22-275-3111

Locations
Japan
Sendai Shakaihoken Hospital Not yet recruiting
Sendai, Miyagi, Japan, 981-8501
Contact: Toshinobu Sato, MD, PhD    +81-22-275-3111      
Sponsors and Collaborators
Sendai Shakaihoken Hospital
Investigators
Study Director: Toshinobu Sato, MD, PhD Sendai Shakaihoken Hospital
  More Information

No publications provided

Responsible Party: TOSHINOBU SATO, MD, PhD, Sendai Shakaihoken Hospital
ClinicalTrials.gov Identifier: NCT01726868     History of Changes
Other Study ID Numbers: CCE-001
Study First Received: November 10, 2012
Last Updated: April 1, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Embolism
Embolism, Cholesterol
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Embolism, Fat

ClinicalTrials.gov processed this record on August 21, 2014