Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage (FMIICH)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Drug: Fingolimod

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhihong Li; Phone Number: +86-13709183909; Email: 409615390@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fingolimod group; 0.5mg/day oral fingolimod over a course of 3 consecutive days	Drug: Fingolimod; 0.5mg/day oral fingolimod over a course of 3 consecutive days
No Intervention: Control group; No fingolimod will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Rankin Scale	Neurological outcome, range: 0-6. The higher scores mean a worse outcome.	90 days and 180 days after ICH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Modified Barthel Index	Neurological outcome, range: 0-100. The higher scores mean a better outcome.	90 days and 180 days after ICH
Montreal Cognitive Assessment Scale	Neurological outcome, range: 0-30. The higher scores mean a better outcome.	90 days and 180 days after ICH
Volume of perihematomal edema	Volume of perihematomal edema measured on head Computerised Tomography	Baseline on admission, 7 days and 14 days after ICH

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Yan Qu, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 11, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: 202307-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: the baseline characteristic, treatments and functional outcomes will be shared with other researchers
• IPD Sharing Time Frame: the data will be available after the study is finished for 3 years
• IPD Sharing Access Criteria: Individual participant data will be shared on a website available to other researchers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No