Back to resultsFingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage (FMIICH)
Primary Purpose
Intracerebral Hemorrhage
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fingolimod
Sponsored by
About this trial
This is an interventional treatment trial for Intracerebral Hemorrhage
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fingolimod group
Control group
Arm Description
0.5mg/day oral fingolimod over a course of 3 consecutive days
No fingolimod will be administered.
Outcomes
Primary Outcome Measures
modified Rankin Scale
Neurological outcome, range: 0-6. The higher scores mean a worse outcome.
Secondary Outcome Measures
The National Institutes of Health Stroke Scale
Neurological outcome, range: 0-42. The higher scores mean a worse outcome.
Modified Barthel Index
Neurological outcome, range: 0-100. The higher scores mean a better outcome.
Montreal Cognitive Assessment Scale
Neurological outcome, range: 0-30. The higher scores mean a better outcome.
Volume of perihematomal edema
Volume of perihematomal edema measured on head Computerised Tomography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06087965
Brief Title
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Acronym
FMIICH
Official Title
Efficacy and Safety of Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 11, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fingolimod group
Arm Type
Experimental
Arm Description
0.5mg/day oral fingolimod over a course of 3 consecutive days
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No fingolimod will be administered.
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Description
0.5mg/day oral fingolimod over a course of 3 consecutive days
Primary Outcome Measure Information:
Title
modified Rankin Scale
Description
Neurological outcome, range: 0-6. The higher scores mean a worse outcome.
Time Frame
90 days and 180 days after ICH
Secondary Outcome Measure Information:
Title
The National Institutes of Health Stroke Scale
Description
Neurological outcome, range: 0-42. The higher scores mean a worse outcome.
Time Frame
90 days and 180 days after ICH
Title
Modified Barthel Index
Description
Neurological outcome, range: 0-100. The higher scores mean a better outcome.
Time Frame
90 days and 180 days after ICH
Title
Montreal Cognitive Assessment Scale
Description
Neurological outcome, range: 0-30. The higher scores mean a better outcome.
Time Frame
90 days and 180 days after ICH
Title
Volume of perihematomal edema
Description
Volume of perihematomal edema measured on head Computerised Tomography
Time Frame
Baseline on admission, 7 days and 14 days after ICH
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihong Li
Phone
+86-13709183909
Email
409615390@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Qu
Organizational Affiliation
Tang-Du Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage
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