Reactive Oxygen Species (ROS) Scavenger in Adult Hemorrhagic Stroke Patients
- Conditions
- Diseases of the nervous system
- Registration Number
- KCT0004628
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
1.Age =18 years and = 80 years
2.Acute ICH due to hypertensive, cerebral amyloid angiopathy (CAA), arterio-venous malformation (AVM), cavernous malformation (CM) or venous thrombosis
3.Brain tumor bleeding
4.Cerebral infarct
5.Expected ICU stay > 48 hours
1) Trauma related brain hemorrhage
2) ICH secondary to hematologic malignancy (acute myeloid leukemia, acute lymphocytic leukemia)
3) ICH due to disease like moyamoya, aneurysmal SAH or hemorrhagic cyst rupture like arachnoid cyst
4) ICH due to thrombocytopenia (< 50 000 x10³/uL) or coagulopathy (> 2 INR)
5) Patient taking antiplatelets (aspirin, clopidogrel or cilostazole) or anticoagulation (heparin or low-molecular weight heparin [LMWH], vitamin K antagonist (warfarin) or direct oral anticoagulants [DOAC])
6) History of cerebrovascular, tumor or any other disease that makes difficult to evaluate the extent of hemorrhage or edema from the current CT
7) Brain death or imminent death (not expected to be in ICU for more than 48 hours)
8) Pregnant patient
9) Liver cirrhosis – Child’s class C liver disease
10) Seizure disorder requiring anticonvulsant medication
11) Post - cardiac arrest with suspected significant anoxic brain injury
12) DNR (do not resuscitate) ordered patients
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 30-day neurologic outcome using mRS
- Secondary Outcome Measures
Name Time Method Duration of intensive care unit admission;Time to reach target sedation level (RASS target: -2 - 0);The length of ICU stay;Length of hospital stay;Perihematomal edema changes;vasospasm