Actively Recruiting
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
Led by National Taiwan University Hospital · Updated on 2026-03-09
100
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Cilostazol in Promoting Hematoma Clearance After Intracerebral Hemorrhage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 to 80 years
- Intracerebral hemorrhage located in the thalamus or basal ganglia
- ICH score less than 3 with hematoma volume not greater than 15 ml
- Admitted within 24 hours since ICH onset
- Patient or legal representative agrees to participate and accept study tests
- Normal bone marrow and hematopoiesis (red blood cells, white blood cells, platelets within reference values)
- Normal liver function (AST, ALT, and gamma-GT within reference values)
- Normal kidney function (BUN, creatinine, and eGFR within reference values)
- Normal coagulation function (platelet count, PT, aPTT, INR within reference values)
You will not qualify if you...
- Imaging after ICH showing high bleeding risks such as spot sign, new or expanding intraventricular hemorrhage, irregular or heterogeneous hematoma, or hematoma expansion
- ICH located in cerebral area, below cerebellar tentorium, or ICH score greater than 3
- Surgical intervention recommended (decompressive craniotomy or hematoma evacuation)
- History of brain trauma, structural/metabolic/neuroinflammatory brain diseases, or brain tumors
- Unable to tolerate imaging studies due to agitation, unstable condition, or incompatible devices
- Contraindications to MRI contrast agents including chronic renal failure
- Pregnant, expecting pregnancy, or breastfeeding within six months
- Taking oral antiplatelet or anticoagulant medications at time of ICH
- Contraindications to cilostazol including heart failure, coagulopathy, serious arrhythmias, recent myocardial infarction, prior coronary intervention, active bleeding, or severe liver/kidney failure
- Poor blood pressure control (systolic >160 mmHg despite medication)
- Unstable neurological status (NIHSS increase >4 or new conscious changes during admission)
- Life expectancy less than three months
- Allergy to study medication ingredients or deemed unsuitable by investigators
- Patient or legal guardian refuses participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Not Required For This Country, Taiwan, 100225
Actively Recruiting
Research Team
H
Hsin-Hsi Tsai, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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