Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage

Sponsor
Xuanwu Hospital, Beijing
Study ID
NCT07665827
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Diseases
  • Cerebral Hemorrhage
  • Cerebral Hemorrhage, Hypertensive
  • Cerebrovascular Disorders
  • Hemorrhage
  • Hemorrhagic Stroke, Intracerebral
  • Intracranial Hemorrhages
  • Nervous System Diseases
  • Stroke
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Jun 24, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
706 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mobile Stroke Unit Management
    ICH patients treated in the Mobile Stroke Unit
  • Active Comparator: Standard Management
    ICH patients receiving standard management

Primary Outcome Measure

Proportion of no or moderate disability [ Time Frame: 90 ± 7 days ]

Central Contacts

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