Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage
NCT07665827 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 706
Last updated 2026-06-24
Summary
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.
Conditions
- Nervous System Diseases
- Cerebrovascular Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Hemorrhage
- Intracranial Hemorrhages
- Cerebral Hemorrhage
- Cerebral Hemorrhage, Hypertensive
- Stroke
- Hemorrhagic Stroke, Intracerebral
Interventions
- OTHER
-
Mobile Stroke Unit Management
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.
- OTHER
-
Standard Management
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.
Sponsors & Collaborators
-
Beijing Emergency Medical Center
collaborator OTHER -
Huizhou Third People's Hospital, Guangzhou Medical University
collaborator OTHER -
Suzhou First People's Hospital
collaborator UNKNOWN -
Nanyang Nanshi Hospital
collaborator OTHER -
Xuanwu Hospital, Beijing
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2028-04-30
- Completion
- 2028-07-31
Countries
- China
Study Locations
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