Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01726868
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
85 Years
Study:
NCT01726868
Study Brief:
Protocol Section:
NCT01726868