Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage (FMIICH)

October 17, 2023 updated by: Tang-Du Hospital

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

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 90 days and 180 days after ICH
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
Time Frame: 90 days and 180 days after ICH
Neurological outcome, range: 0-42. The higher scores mean a worse outcome.
90 days and 180 days after ICH
Modified Barthel Index
Time Frame: 90 days and 180 days after ICH
Neurological outcome, range: 0-100. The higher scores mean a better outcome.
90 days and 180 days after ICH
Montreal Cognitive Assessment Scale
Time Frame: 90 days and 180 days after ICH
Neurological outcome, range: 0-30. The higher scores mean a better outcome.
90 days and 180 days after ICH
Volume of perihematomal edema
Time Frame: Baseline on admission, 7 days and 14 days after ICH
Volume of perihematomal edema measured on head Computerised Tomography
Baseline on admission, 7 days and 14 days after ICH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Investigators

  • Study Chair: Yan Qu, Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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