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.
Intensive BP-lowering initiated within 3 hours of intracerebral haemorrhage onset may reduce the risk of hematoma expansion and improve functional outcome. This trial is designed to evaluate whether, compared with Emergency Medical Services (EMS), the Mobile Stroke Unit (MSU) can improve outcomes in patients with spontaneous intracerebral hemorrhage by reducing onset-to-treatment time. This is a multicenter, prospective, open-label, blinded endpoint, alternating week, cluster-controlled trial. Patients with suspected stroke who present within 3 hours of symptom onset and have a systolic blood pressure ≥150 mmHg will be enrolled in the trial. The primary analysis population will consist of patients with spontaneous intracerebral hemorrhage confirmed by computed tomography (CT). Patients will be assigned according to alternating weekly MSU or EMS deployment. During MSU weeks, patients undergo on-board CT, and those with intracerebral hemorrhage receive immediate prehospital blood pressure lowering. During EMS weeks, 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. Clinical efficacy will be determined by demonstrating an improvement in functional outcome, as assessed by blinded evaluation of the 90-day utility-weighted modified Rankin Scale (mRS). It is hypothesized that the MSU pathway, compared to EMS, can enable earlier assessment and initiation of blood pressure lowering within 3 hours of symptom onset in patients with spontaneous intracerebral hemorrhage, thereby improving functional outcomes at 90 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
706
MSU 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.
A 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.
Xuanwu Hospital
Beijing, Beijing Municipality, China
Proportion of no or moderate disability
defined by mRS 0-3
Time frame: 90 ± 7 days
Hematoma volume
evaluated by CT
Time frame: 24±6 hours
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)
Time frame: 90 ± 7 days
Proportion of without severe disability
defined by mRS0-4
Time frame: 90±7 days
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.
Time frame: 24 ± 6 hours and 7 ± 1 days
In-hospital mortality rate
Frequency of patients dying within the duration of the hospital stay after admission for stroke
Time frame: 7 ±1 days /discharge
All-cause mortality rate
Time frame: 90±7 days
Proportion of surgical interventions
Interventions include hematoma evacuation, external ventricular drainage, and craniectomy.
Time frame: Within 7±1 days
Incidence of severe hypotension events
Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis.
Time frame: 24±12 hours, 7±1 days
Health-related quality of life
Assessment by European Quality of Life - 5 Dimensions (EQ-5D). EQ-5D index scores range from less than 0 to 1, with higher scores indicating better health-related quality of life.
Time frame: 90±7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.