Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

— FMIICH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06087965
• Other study ID #: 202307-11
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 11, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Tang-Du Hospital
• Contact: Zhihong Li
• Phone: +86-13709183909
• Email: 409615390[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Fingolimod
0.5mg/day oral fingolimod over a course of 3 consecutive days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	modified Rankin Scale	Neurological outcome, range: 0-6. The higher scores mean a worse outcome.	90 days and 180 days after ICH
Secondary	The National Institutes of Health Stroke Scale	Neurological outcome, range: 0-42. The higher scores mean a worse outcome.	90 days and 180 days after ICH
Secondary	Modified Barthel Index	Neurological outcome, range: 0-100. The higher scores mean a better outcome.	90 days and 180 days after ICH
Secondary	Montreal Cognitive Assessment Scale	Neurological outcome, range: 0-30. The higher scores mean a better outcome.	90 days and 180 days after ICH
Secondary	Volume of perihematomal edema	Volume of perihematomal edema measured on head Computerised Tomography	Baseline on admission, 7 days and 14 days after ICH