Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
NCT ID: NCT01726868
Last Updated: 2016-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
35 participants
INTERVENTIONAL
2013-07-31
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Liposorber LA-15 System
Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.
Interventions
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Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.
Eligibility Criteria
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Inclusion 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 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.
20 Years
85 Years
ALL
No
Sponsors
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Japan Community Health Care Organization Sendai Hospital
OTHER
Responsible Party
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TOSHINOBU SATO
MD, PhD
Principal Investigators
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Toshinobu Sato, MD, PhD
Role: STUDY_DIRECTOR
Japan Community Health Care Organization Sendai Hospital
Locations
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Sendai Shakaihoken Hospital
Sendai, Miyagi, Japan
Countries
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Central Contacts
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Toshinobu Sato, MD, PhD
Role: CONTACT
Facility Contacts
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Toshinobu Sato, MD, PhD
Role: primary
References
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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.
Other Identifiers
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CCE-001
Identifier Type: -
Identifier Source: org_study_id
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