Clinical trial NCT01726868: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cholesterol Embolism
Lead sponsor: Japan Community Health Care Organization Sendai Hospital
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

  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.

Primary outcomes:
measure: Incidence of chronic hemodialysis
timeFrame: Six months
Secondary outcomes:
measure: Dose of drugs
timeFrame: Six months
measure: Incidence of lower limb amputation
timeFrame: Six months
measure: Incidence of gangrene
timeFrame: Six months
measure: Incidence of multi organ failure
timeFrame: Six months
measure: Survival rate
timeFrame: Six months
measure: Incidence of adverse events
timeFrame: Six months
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Sendai Shakaihoken Hospital
state: Miyagi
Study officials:
affiliation: Japan Community Health Care Organization Sendai Hospital
name: Toshinobu Sato, MD, PhD
role: STUDY_DIRECTOR
References:
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.