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

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ClinicalTrials.gov Identifier: NCT01726868
Recruitment Status : Recruiting
First Posted : November 15, 2012
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
TOSHINOBU SATO, Japan Community Health Care Organization Sendai Hospital

Tracking Information
First Submitted Date  ICMJE November 10, 2012
First Posted Date  ICMJE November 15, 2012
Last Update Posted Date July 4, 2016
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
Incidence of chronic hemodialysis [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01726868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Official Title  ICMJE Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Brief Summary The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cholesterol Embolism
Intervention  ICMJE Device: Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.
Study Arms  ICMJE Experimental: Liposorber LA-15 System
Intervention: Device: Liposorber LA-15 System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 11, 2012)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Toshinobu Sato, MD, PhD +81-22-275-3111
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01726868
Other Study ID Numbers  ICMJE CCE-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TOSHINOBU SATO, Japan Community Health Care Organization Sendai Hospital
Study Sponsor  ICMJE Japan Community Health Care Organization Sendai Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Toshinobu Sato, MD, PhD Japan Community Health Care Organization Sendai Hospital
PRS Account Japan Community Health Care Organization Sendai Hospital
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP