Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

NCT ID: NCT06087965

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2025-12-30

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fingolimod group

0.5mg/day oral fingolimod over a course of 3 consecutive days

Group Type: EXPERIMENTAL

Fingolimod

Intervention Type: DRUG

0.5mg/day oral fingolimod over a course of 3 consecutive days

Control group

No fingolimod will be administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fingolimod

0.5mg/day oral fingolimod over a course of 3 consecutive days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Qu

Role: STUDY_CHAIR

Tang-Du Hospital

Central Contacts

Zhihong Li

Role: CONTACT

409615390@qq.com

+86-13709183909

Other Identifiers

202307-11

Identifier Type: -

Identifier Source: org_study_id