Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Primary Purpose
Cholesterol Embolism
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Liposorber LA-15 System
Sponsored by
About this trial
This is an interventional treatment trial for Cholesterol Embolism
Eligibility 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.
- 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.
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.
Sites / Locations
- Sendai Shakaihoken HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liposorber LA-15 System
Arm Description
Outcomes
Primary Outcome Measures
Incidence of chronic hemodialysis
Secondary Outcome Measures
Dose of drugs
Incidence of lower limb amputation
Incidence of gangrene
Incidence of multi organ failure
Survival rate
Incidence of adverse events
Full Information
NCT ID
NCT01726868
First Posted
November 10, 2012
Last Updated
June 30, 2016
Sponsor
Japan Community Health Care Organization Sendai Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01726868
Brief Title
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Official Title
Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Japan Community Health Care Organization Sendai Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholesterol Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liposorber LA-15 System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Liposorber LA-15 System
Intervention Description
Six sessions of blood purification treatment with Liposorber LA-15 System.
Primary Outcome Measure Information:
Title
Incidence of chronic hemodialysis
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Dose of drugs
Time Frame
Six months
Title
Incidence of lower limb amputation
Time Frame
Six months
Title
Incidence of gangrene
Time Frame
Six months
Title
Incidence of multi organ failure
Time Frame
Six months
Title
Survival rate
Time Frame
Six months
Title
Incidence of adverse events
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toshinobu Sato, MD, PhD
Phone
+81-22-275-3111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshinobu Sato, MD, PhD
Organizational Affiliation
Japan Community Health Care Organization Sendai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sendai Shakaihoken Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
981-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshinobu Sato, MD, PhD
Phone
+81-22-275-3111
12. IPD Sharing Statement
Citations:
PubMed Identifier
34216189
Citation
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.
Results Reference
derived
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Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
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