Clinical Study to Evaluate the Efficacy of Blood Purifica... | NCT01726868

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

NCT01726868

Sponsor

Japan Community Health Care Organization Sendai Hospital

Status

Unknown status

Last Update Posted

Jul 4, 2016Estimated

Enrollment

35Estimated

Phase

Phase 2

Conditions

Cholesterol Embolism

Interventions

Liposorber LA-15 System

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Nov 10, 2012

First Submission Date that Met QC Criteria

Nov 11, 2012

First Posted Date

Nov 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2016

Last Update Posted Date

Jul 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Label	Type	Description	Intervention Names
Liposorber LA-15 System	Experimental		Device: Liposorber LA-15 System

Name	Type	Description	Arm Group Labels	Other Names
Liposorber LA-15 System	Device	Six sessions of blood purification treatment with Liposorber LA-15 System.	Liposorber LA-15 System

Measure	Description	Time Frame
Incidence of chronic hemodialysis		Six months

Measure	Description	Time Frame
Dose of drugs		Six months
Incidence of lower limb amputation		Six months
Incidence of gangrene

Eligibility Module

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Toshinobu Sato, MD, PhD	Contact	+81-22-275-3111

Name	Affiliation	Role
Toshinobu Sato, MD, PhD	Japan Community Health Care Organization Sendai Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Sendai Shakaihoken Hospital	Recruiting	Sendai	Miyagi	981-8501	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34216189	Derived	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.

ID	Term
D004620	Embolism, Fat
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases