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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT06361433
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age between 20 and 70 years
* 2\. Clinical diagnosis of intracerebral hemorrhage 12 month or more from onset
* 3\. Hemorrhagic location of unilateral basal ganglia or thalamus
* 4\. Moderate to severe neurological symptoms; mRS 3 or 4, and Brunnstrom stage Ⅲ or IV
* 5\. No significant neurological impairment before hemorrhage (Pre-hemorrhagic mRS of 0 or 1)
* 6\. Subjects who can give informed consent by its self
Exclusion Criteria:
* 1\. Severe microbleeds found by T2\*
* 2\. Hemorrhagic cavity less than 2 mL
* 3\. The hemorrhage is due to arteriovenous malformation, cerebral aneurysm, and Moyamoya disease
* 4\. Subject showing obvious communication between the hemorrhagic cavity and lateral ventricle on MRI
* 5\. Subject showing severe lower extremity contracture (Maximum knee extension less than -15 degrees, Maximum ankle flexion less than 0 degree)
* 6\. Subject's body weight less than 45 kg for male and 40kg for female
* 7\. Anaemia (Hg \< 10·0 g/dL)
* 8\. Thrombocytopaenia (platelet count \< 100,000/mm3)
* 9\. Severe heart disease (ischaemic heart disease, heart failure)
* 10\. Uncontrolled hypertension, despite antihypertensive therapy
* 11\. Carriers of infectious disease: syphilis, HBV, HCV, HIV-1/HIV-2, HTLV-1, parvovirus B19
* 12\. Pregnant or lactating or expecting to become pregnant during the study
* 13\. History of malignancy
* 14\. Systemic organ failure ALT ≤ 3·0× upper limit of normal Total bilirubin ≤ 1·5× upper limit of normal Serum creatinine ≤ 1·5× upper limit of normal
* 15\. Known serious allergy to any agents used in the study
* 16\. Contraindication for magnetic resonance imaging
* 17\. Any condition that in the judgement of the investigator would place the patient at undue risk
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06361433
Study Brief:
Protocol Section:
NCT06361433