Nervous System DiseasesMSU-ICHNCT07665827
Efficacy and Safety of Antihypertensive Treatment With Mobile Stroke Units in Ultra-Early Intracerebral Hemorrhage
A study testing Mobile Stroke Unit Management and Standard Management in people with Nervous System Diseases and Cerebrovascular Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nervous System Diseases, Cerebrovascular Disorders, Cardiovascular Diseases
- What is being tested?
- Mobile Stroke Unit Management and Standard Management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History and physical/neurological examination consistent with acute stroke.
- Age ≥18 years;
- Time from symptom onset to enrollment <3 hours (onset defined as last known normal).
- Systolic blood pressure ≥150 mmHg and ≤220 mmHg;
- Pre-stroke modified Rankin Scale (mRS) score ≤2;
- Informed consent obtained from the subject or a legally authorized representative.
Who cannot join
- Glasgow Coma Scale (GCS) score ≤5.
- Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.
- Malignant disease or other serious primary illness with a life expectancy of <3 months.
- Current participation in another interventional randomized clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xuanwu Hospital
Beijing, Beijing Municipality, 100053
Xiuhai Guo, MD, PhD, 86-10-83198852, guoxhxuan@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Nervous System Diseases, Cerebrovascular Disorders, Cardiovascular Diseases, Vascular Diseases, Hemorrhage, Intracranial Hemorrhages
- Being tested
- Mobile Stroke Unit Management, Standard Management
- Keywords
- intracerebral hemorrhage, mobile stroke units, Intensive blood pressure lowering
- Medical subject headings
- Nervous System Diseases, Cerebrovascular Disorders, Cardiovascular Diseases, Vascular Diseases, Hemorrhage, Intracranial Hemorrhages, Cerebral Hemorrhage, Intracranial Hemorrhage, Hypertensive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Stroke Unit ManagementOther
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 ManagementOther
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 group | Role | What they receive |
|---|---|---|
| Mobile Stroke Unit Management | Experimental | ICH patients treated in the Mobile Stroke Unit Receives: Other: Mobile Stroke Unit Management |
| Standard Management | Active comparator | ICH patients receiving standard management Receives: Other: Standard Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of no or moderate disability
defined by mRS 0-3
Measured: 90 ± 7 days
Secondary outcomes (9)
Hematoma volume
evaluated by CT
Measured: 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)
Measured: 90 ± 7 days
Proportion of without severe disability
defined by mRS0-4
Measured: 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.
Measured: 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
Measured: 7 ±1 days /discharge
All-cause mortality rate
Measured: 90±7 days
Proportion of surgical interventions
Interventions include hematoma evacuation, external ventricular drainage, and craniectomy.
Measured: 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.
Measured: 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.
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 706 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Emergency Medical Center, Huizhou Third People's Hospital, Guangzhou Medical University, The First Affiliated Hospital of Soochow University, Nanyang Nanshi Hospital
- Responsible party
- Principal investigator, Xiuhai Guo,MD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665827
- Sponsor's protocol ID
- [2026]093-003
- Acronym
- MSU-ICH
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07665827
- Acronym / sponsor ID
- MSU-ICH / [2026]093-003
- Conditions
- Nervous System Diseases, Cerebrovascular Disorders, Cardiovascular Diseases, Vascular Diseases, Hemorrhage, Intracranial Hemorrhages
- Keywords
- intracerebral hemorrhage, mobile stroke units, Intensive blood pressure lowering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 706 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Emergency Medical Center, Huizhou Third People's Hospital, Guangzhou Medical University, The First Affiliated Hospital of Soochow University, Nanyang Nanshi Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Stroke Unit Management | Experimental | Other: Mobile Stroke Unit ManagementICH patients treated in the Mobile Stroke Unit |
| Standard Management | Active comparator | Other: Standard ManagementICH patients receiving standard management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- History and physical/neurological examination consistent with acute stroke.
- Age ≥18 years;
- Time from symptom onset to enrollment <3 hours (onset defined as last known normal).
- Systolic blood pressure ≥150 mmHg and ≤220 mmHg;
- Pre-stroke modified Rankin Scale (mRS) score ≤2;
Key exclusion criteria (4 listed)
- Glasgow Coma Scale (GCS) score ≤5.
- Contraindications to intensive blood pressure lowering, including severe arterial stenosis or high-grade stenotic valvular heart disease.
- Malignant disease or other serious primary illness with a life expectancy of <3 months.
- Current participation in another interventional randomized clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Stroke Unit ManagementMSU 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 | Mobile Stroke Unit Management |
| Standard ManagementA 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. | Other | Standard Management |
Primary outcome
Proportion of no or moderate disability
Time frame: 90 ± 7 days
defined by mRS 0-3
9 secondary outcomes
Hematoma volume
Time frame: 24±6 hours
Modified Rankin Scale (mRS) score
Time frame: 90 ± 7 days
Proportion of without severe disability
Time frame: 90±7 days
National Institutes of Health Stroke Scale (NIHSS) score
Time frame: 24 ± 6 hours and 7 ± 1 days
In-hospital mortality rate
Time frame: 7 ±1 days /discharge
All-cause mortality rate
Time frame: 90±7 days
Proportion of surgical interventions
Time frame: Within 7±1 days
Incidence of severe hypotension events
Time frame: 24±12 hours, 7±1 days
Health-related quality of life
Time frame: 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Stroke Unit Management and Standard Management in people with Nervous System Diseases and Cerebrovascular Disorders, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Wang, MD (86-159-6477-4581, wangxinyuneuron@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of no or moderate disability (time frame: 90 ± 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.