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

Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage: A Multicenter, Prospective, Cluster-Randomized, Open-Label, Blinded-Endpoint Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Nervous System Diseases; Hemorrhage; Intracranial Hemorrhages; Cerebral Hemorrhage; Hemorrhagic Stroke, Intracerebral; Cerebral Hemorrhage, Hypertensive
• Intervention / Treatment: Other: Mobile Stroke Unit Management; Other: Standard Management

Detailed Description

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
• Enrollment (Estimated): 706
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuhai Guo, MD, PhD; Phone Number: 86-10-83198852; Email: guoxhxuan@126.com
• Study Contact Backup: Name: Xinyu Wang, MD; Phone Number: 86-159-6477-4581; Email: wangxinyuneuron@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100053
      • Xuanwu Hospital
      • Contact: Xiuhai Guo, MD, PhD; Phone Number: 86-10-83198852; Email: guoxhxuan@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. History and physical/neurological examination consistent with acute stroke.
2. Age ≥18 years;
3. Time from symptom onset to enrollment <3 hours (onset defined as last known normal).
4. Systolic blood pressure ≥150 mmHg and ≤220 mmHg;
5. Pre-stroke modified Rankin Scale (mRS) score ≤2;
6. Informed consent obtained from the subject or a legally authorized representative.

Exclusion Criteria:

1. Glasgow Coma Scale (GCS) score ≤5.
2. Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.
3. Malignant disease or other serious primary illness with a life expectancy of <3 months.
4. Current participation in another interventional randomized clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Stroke Unit Management; ICH patients treated in the Mobile Stroke Unit	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.
Active Comparator: Standard Management; ICH patients receiving standard management	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of no or moderate disability	defined by mRS 0-3	90 ± 7 days

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Huizhou Third People's Hospital, Guangzhou Medical University; Beijing Emergency Medical Center; Suzhou First People's Hospital; Nanyang nanshi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 26, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: intracerebral hemorrhage; Intensive blood pressure lowering; mobile stroke units
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhagic Stroke; Stroke; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Cerebrovascular Disorders; Hemorrhage; Cerebral Hemorrhage; Intracranial Hemorrhages; Intracranial Hemorrhage, Hypertensive
• Other Study ID Numbers: [2026]093-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No