Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

202307-11

Intracerebral hemorrhage (ICH) is a critical disease of public health importance. Inflammatory mechanisms play a significant role in ICH. Thus, immune targets are supposed to be effective in protecting the neurological function of ICH. Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator. It has been widely used in autoimmune disease and has also been testified effective in ICH who received conservative treatment. The present study aims to evaluate the efficiency and safety of fingolimod for ICH with minimal invasive treatment.

2023-10-11

2025-06-30

2025-12-30

Not yet recruiting

Early phase I

40

Inclusion Criteria: * spontaneous basal ganglia ICH with volume larger than 20ml; * age: 18-80 years; * admission Glasgow Coma Scale score: 5-12; * admitting to hospital with 24 hours after injury; * no fever or signs infection on admission to hospital; * admission heart rate≥60/min on admission. Exclusion Criteria: * refuse follow-up; * received operation before admitting to hospital; * hemorrhage by tumor, arteriovenous malformation, arterial aneurysm, hematological disease or traumatic brain injury; * severe vomiting; * mRS\>1 before ICH; * prior history of bradycardia; * prior history of Atrioventricular block; * prior history of traumatic brain injury, craniotomy or stroke; * expected lifetime less than 1 year; * undergoing antitumor, antiepileptic, immunomodulatory or immunosuppressive therapy; * admitting to other ongoing study; * systemic disease: uremia, liver cirrhosis, malignant tumor, mental disease, drug or alcohol dependence; * received anticoagulant or antiplatelet therapy within 7 days; * intraventricular hemorrhage requires intraventricular catheterization.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2023-10-18