Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism
This study is not yet open for participant recruitment.
Verified April 2013 by Sendai Shakaihoken Hospital
Sponsor:
Sendai Shakaihoken Hospital
Information provided by (Responsible Party):
TOSHINOBU SATO, Sendai Shakaihoken Hospital
ClinicalTrials.gov Identifier:
NCT01726868
First received: November 10, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
The aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholesterol Embolism |
Device: Liposorber LA-15 System |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Clinical Study to Evaluate the Efficacy of Blood Purification Therapy on Cholesterol Crystal Embolism |
Resource links provided by NLM:
Further study details as provided by Sendai Shakaihoken Hospital:
Primary Outcome Measures:
- Incidence of chronic hemodialysis [ Time Frame: Six months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Dose of drugs [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Incidence of lower limb amputation [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Incidence of gangrene [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Incidence of multi organ failure [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Survival rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: Six months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 35 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Liposorber LA-15 System |
Device: Liposorber LA-15 System
Six sessions of blood purification treatment with Liposorber LA-15 System.
|
Eligibility| Ages Eligible for Study: | 20 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726868
Contacts
| Contact: Toshinobu Sato, MD, PhD | +81-22-275-3111 |
Locations
| Japan | |
| Sendai Shakaihoken Hospital | Not yet recruiting |
| Sendai, Miyagi, Japan, 981-8501 | |
| Contact: Toshinobu Sato, MD, PhD +81-22-275-3111 | |
Sponsors and Collaborators
Sendai Shakaihoken Hospital
Investigators
| Study Director: | Toshinobu Sato, MD, PhD | Sendai Shakaihoken Hospital |
More Information
No publications provided
| Responsible Party: | TOSHINOBU SATO, MD, PhD, Sendai Shakaihoken Hospital |
| ClinicalTrials.gov Identifier: | NCT01726868 History of Changes |
| Other Study ID Numbers: | CCE-001 |
| Study First Received: | November 10, 2012 |
| Last Updated: | April 1, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Embolism Embolism, Cholesterol Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Embolism, Fat |
ClinicalTrials.gov processed this record on May 23, 2013