Clinical trial NCT06087965: Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Official title: Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Intracerebral Hemorrhage
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 40 ICH patients who meet the inclusion criteria will be enrolled in the present study.

All ICH patients will be screened. If meeting the including criteria, the investigators will contact the family, explain the study, and send a consent form for review.

After obtaining written consent from the family, patients randomly assigned to the fingolimod group will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days. Patients assigned to the control group will not receive fingolimod. All patients will receive minimal invasive puncture and drainage of hematoma. The investigators will evaluate the neurofunctional before and 30 days, 90 days and 180 days after oral fingolimod. CT scan will be performed at before, 7 and 14 days after oral fingolimod. 5ml intravenous blood for flow cytometry is also taken before and 1day, 3days, 7days after fingolimod use.

Eligibility criteria: 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.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 90 days and 180 days after ICH
Secondary outcomes:
measure: The National Institutes of Health Stroke Scale
timeFrame: 90 days and 180 days after ICH
measure: Modified Barthel Index
timeFrame: 90 days and 180 days after ICH
measure: Montreal Cognitive Assessment Scale
timeFrame: 90 days and 180 days after ICH
measure: Volume of perihematomal edema
timeFrame: Baseline on admission, 7 days and 14 days after ICH
Other outcomes:
Locations:
Study officials:
affiliation: Tang-Du Hospital
name: Yan Qu
role: STUDY_CHAIR
References: