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| Name | Class |
|---|---|
| Beijing Emergency Medical Center | OTHER |
| Huizhou Third People's Hospital, Guangzhou Medical University | OTHER |
| Suzhou First People's Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Stroke Unit Management | Experimental | ICH patients treated in the Mobile Stroke Unit |
|
| Standard Management | Active Comparator | ICH patients receiving standard management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Stroke Unit Management | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of no or moderate disability | defined by mRS 0-3 | 90 ± 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma volume | evaluated by CT | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyu Wang, MD | Contact | 86-159-6477-4581 | wangxinyuneuron@163.com | |
| Xiuhai Guo, MD, PhD | Contact | 86-10-83198852 | guoxhxuan@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | Beijing Municipality | 100053 | China |
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| Nanyang nanshi Hospital |
| UNKNOWN |
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|
| Standard Management | Other | 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. |
|
| 90 ± 7 days |
| Proportion of without severe disability | defined by mRS0-4 | 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. | 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 | 7 ±1 days /discharge |
| All-cause mortality rate | 90±7 days |
| Proportion of surgical interventions | Interventions include hematoma evacuation, external ventricular drainage, and craniectomy. | 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. | 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. | 90±7 days |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| D002543 | Cerebral Hemorrhage |
| D020299 | Intracranial Hemorrhage, Hypertensive |
| D020521 | Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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