Intracerebral hemorrhage (ICH) is a dangerous form of stroke with high mortality rate. Other than evacuating the hematoma with surgical procedures, there is no current effective internal medicine treatment. Currently, there are many novel internal medicine treatment under development, one of which is the promotion of endogenous hematoma clearance. Our team recently found out that the meningeal lymphatic system plays an important role in clearing hematoma post-ICH, meaning that promoting the drainage function of the meningeal lymphatic system may have a certain level of help for improving the prognosis of ICH.
Cilostazol is an anti-PDE3 type antiplatelet agent with the function of preventing peripheral arterial occlusion disease and stroke. Cilostazol has been proven to promote lymphatic endothelial cell proliferation and the drainage function of the lymphatic system. Our animal research points out that Cilostazol speeds up hematoma clearance post-ICH and generates neuroprotective effects, thereby improving prognosis and providing a new internal medicine treatment for ICH.
Due to the fact that there is no clinical trial looking into the hematoma resorption effect of Cilostazol in ICH patients, this trials aims to understand the safety and hematoma resorption efficacy of Cilostazol in acute ICH patients. Investigators estimate to enroll 100 patients in National Taiwan University Hospital (NTUH) within 3 years. The patients would be randomized into two groups, one receiving Cilostazol (two weeks, 50mg BID) and conventional treatment, and the other group receiving only conventional treatment. Investigators will assess the patients' neurological outcome and functional aspects (NIHSS, modified Rankin Scale) two weeks / one month / three months after ICH. Investigators will also use MRI to measure hematoma size to evaluate hematoma resorption (primary endpoint and safety endpoint). MRI will also be used to measure the drainage effect of the meningeal lymphatics.
Adult patients (at least 20 years old, up to 80 years old)
ICH located in the thalamus or basal ganglia.
ICH score less than 3 (hematoma volume not greater than 15 ml) and was admitted within 24 hours since onset.
The patient or his/her legal representative agrees to join this trial and accept the arrangements of tests within this trial.
Image studies conducted after intracerebral incidence and before enrollment showing higher bleeding risks such as spot sign in computed tomography angiography, new intraventricular hemorrhage (IVH), IVH expansion, irregular hematoma border, heterogenous hematoma component or hematoma expansion.
Intracerebral hemorrhage located in the cerebral area, below the cerebellar tentorium or ICH score greater than 3 (not including 3).
Surgical intevention such as decompressive craniotomy or hematoma evacuation was suggested after evaluation by neurosurgeon.
Patients with history of brain trauma, structural brain disease, metabolic brain disease, neuroinflammatory disease or brain neoplasms.
Parallel
Pletaal 100mg/tab
DrugTwo consecutive weeks of Cilostazol (50mg BID) two days after admission
Conventional internal medicine treatment
Procedure/SurgeryReceives only conventional internal medicine treatment
Hematoma size comparison at 16 days post-ICH
Hematoma size comparison at 16 days post-ICH in the drug treatment group and conventional treatment group by measuring MRI T2WI. Whether taking two consecutive weeks of Cilostazol causes hematoma expansion.
Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH
Subject's National Institute of Health Stroke Scale (0-42) score change 16/30/90 days post-ICH. Higher scores indicating greater severity.
Subject's mRankin Scale score(0-6) change 30/90 days post-ICH compared with pre-treatment status.
Subject's mRankin Scale score(0-6) change 30/90 days post-ICH compared with pre-treatment status. (the ratio of mRS score 0-1 and 0-2, with higher scores indicating greater severity.)
The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group.
The difference of DCE-MRI time to maximal intensity between drug treatment group and conventional treatment group.
Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH.
Hematoma resorption rate difference between drug treatment group and conventional treatment group 16 days post-ICH.
Number of patients that develop hematoma expansion
Safety outcome 1
Number of patient that require surgical evacuation of hematoma or open craniotomy for pressure relief
Safety outcome 2
Number of any adverse event or severe adverse event
Safety outcome 3
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