CClinicalTrials.gg
Status unknownNCT01726868Updated Jul 4, 2016

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

A Phase 2 interventional study of Liposorber LA-15 System in Cholesterol Embolism, sponsored by Japan Community Health Care Organization Sendai Hospital. Status unknown at 1 site in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-04.

Sponsored by Japan Community Health Care Organization Sendai Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
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Study summary

The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.

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Conditions studied

  • Cholesterol Embolism

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03

In context

Embolism

707 studies on the registry are indexed under Embolism; 74 are open to participants now.

This study's planned enrollment of 35 is below the median of 129 across 361 interventional studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

This is the only study on the registry with Japan Community Health Care Organization Sendai Hospital as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Liposorber LA-15 System

    Device: Liposorber LA-15 System

Interventions

  • DeviceLiposorber LA-15 System

    Six sessions of blood purification treatment with Liposorber LA-15 System.

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What researchers measure

Primary outcomes

  1. Incidence of chronic hemodialysis

    Time frame: Six months

Secondary outcomes

  1. Dose of drugs

    Time frame: Six months

  2. Incidence of lower limb amputation

    Time frame: Six months

  3. Incidence of gangrene

    Time frame: Six months

  4. Incidence of multi organ failure

    Time frame: Six months

  5. Survival rate

    Time frame: Six months

  6. Incidence of adverse events

    Time frame: Six months

07

Study locations

1 of 1 sites recruiting
  • Sendai Shakaihoken Hospital
    Sendai, Miyagi 981-8501, Japan
    • Toshinobu Sato, MD, PhD · Contact · +81-22-275-3111
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34216189 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01726868
Lead sponsor
Japan Community Health Care Organization Sendai Hospital
Responsible party
TOSHINOBU SATO (MD, PhD, Japan Community Health Care Organization Sendai Hospital) — Principal investigator
First posted
Nov 15, 2012
Start date
Jul 2013
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jul 4, 2016

Study contacts

Toshinobu Sato, MD, PhD
Contact
+81-22-275-3111
Toshinobu Sato, MD, PhD
study director · Japan Community Health Care Organization Sendai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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