MSU-ICH is a prospective, multicenter, Week-wise-randomized, open-label, blinded-endpoint (PROBE) clinical trial comparing ultra-early prehospital blood pressure lowering delivered by a Mobile Stroke Unit (MSU) with standard Emergency Medical Services (EMS) in patients with spontaneous intracerebral hemorrhage.
History and physical/neurological examination consistent with acute stroke.
Age ≥18 years;
Time from symptom onset to enrollment <3 hours (onset defined as last known normal).
Systolic blood pressure ≥150 mmHg and ≤220 mmHg;
Glasgow Coma Scale (GCS) score ≤5.
Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.
Malignant disease or other serious primary illness with a life expectancy of <3 months.
Current participation in another interventional randomized clinical trial.
Parallel
Mobile Stroke Unit Management
Other interventionMSU is a specialized stroke ambulance equipped with point of care lab, CT scanner, Telemedicine, enabling rapid diagnosis and prehospital management of acute stroke. Patients with suspected stroke undergo on-board CT imaging. Those diagnosed with intracerebral hemorrhage receive immediate prehospital blood pressure lowering. A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists \>150 after 5 minutes.
Standard Management
Other interventionA regular ambulance. The standard management by EMS includes Electrocardiographic（ECG）monitoring, blood glucose management, airway, respiration, and blood pressure control, complication management, intravenous access establishment and other emergency measures. Prehospital antihypertensive treatment is administered only in cases of severe hypertension (systolic blood pressure ≥220 mmHg), with blood pressure lowering initiated after in-hospital CT confirmation.
Proportion of no or moderate disability
defined by mRS 0-3
Hematoma volume
evaluated by CT
Modified Rankin Scale (mRS) score
the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)
Proportion of without severe disability
defined by mRS0-4
National Institutes of Health Stroke Scale (NIHSS) score
The National Institutes of Health Stroke Scale (NIHSS) assesses neurological deficits on a scale ranging from 0 to 42 points. Higher scores indicate more severe neurological impairment.
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Xuanwu Hospital, Beijing
Lead sponsor
Beijing Emergency Medical Center
Collaborator
Huizhou Third People's Hospital, Guangzhou Medical University
Collaborator
Suzhou First People's Hospital
Collaborator
Nanyang nanshi Hospital
Collaborator
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