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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod group | Experimental | 0.5mg/day oral fingolimod over a course of 3 consecutive days |
|
| Control group | No Intervention | No fingolimod will be administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | 0.5mg/day oral fingolimod over a course of 3 consecutive days |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Li | Contact | +86-13709183909 | 409615390@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Qu | Tang-Du Hospital | Study Chair |
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the baseline characteristic, treatments and functional outcomes will be shared with other researchers
the data will be available after the study is finished for 3 years
Individual participant data will be shared on a website available to other researchers.
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| 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 |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |