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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2016 by TOSHINOBU SATO, 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: June 30, 2016
Last verified: June 2016
  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: 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 TOSHINOBU SATO, Sendai Shakaihoken Hospital:

Primary Outcome Measures:
  • Incidence of chronic hemodialysis [ Time Frame: Six months ]

Secondary Outcome Measures:
  • Dose of drugs [ Time Frame: Six months ]
  • Incidence of lower limb amputation [ Time Frame: Six months ]
  • Incidence of gangrene [ Time Frame: Six months ]
  • Incidence of multi organ failure [ Time Frame: Six months ]
  • Survival rate [ Time Frame: Six months ]
  • Incidence of adverse events [ Time Frame: Six months ]

Estimated Enrollment: 35
Study Start Date: July 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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 Recruiting
Sendai, Miyagi, Japan, 981-8501
Contact: Toshinobu Sato, MD, PhD    +81-22-275-3111      
Sponsors and Collaborators
Japan Community Health Care Organization Sendai Hospital
Investigators
Study Director: Toshinobu Sato, MD, PhD Japan Community Health Care Organization Sendai Hospital
  More Information

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: June 30, 2016

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

ClinicalTrials.gov processed this record on June 23, 2017