NCT07665827

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
706

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jun 2026Jul 2028

First Submitted

Initial submission to the registry

April 26, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

April 26, 2026

Last Update Submit

June 18, 2026

Conditions

Nervous System DiseasesCerebrovascular DisordersCardiovascular DiseasesVascular DiseasesHemorrhageIntracranial HemorrhagesCerebral HemorrhageCerebral Hemorrhage, HypertensiveStrokeHemorrhagic Stroke, Intracerebral

Keywords

intracerebral hemorrhagemobile stroke unitsIntensive blood pressure lowering

Outcome Measures

Primary Outcomes (1)

  • Proportion of no or moderate disability

    defined by mRS 0-3

    90 ± 7 days

Secondary Outcomes (9)

  • Hematoma volume

    24±6 hours

  • Modified Rankin Scale (mRS) score

    90 ± 7 days

  • Proportion of without severe disability

    90±7 days

  • National Institutes of Health Stroke Scale (NIHSS) score

    24 ± 6 hours and 7 ± 1 days

  • In-hospital mortality rate

    7 ±1 days /discharge

  • +4 more secondary outcomes

Study Arms (2)

Mobile Stroke Unit Management

EXPERIMENTAL

ICH patients treated in the Mobile Stroke Unit

Other: Mobile Stroke Unit Management

Standard Management

ACTIVE COMPARATOR

ICH patients receiving standard management

Other: Standard Management

Interventions

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.

Mobile Stroke Unit Management
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.

Standard Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Nervous System DiseasesCerebrovascular DisordersCardiovascular DiseasesVascular DiseasesHemorrhageIntracranial HemorrhagesCerebral HemorrhageIntracranial Hemorrhage, HypertensiveStrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xinyu Wang, MD

CONTACT

86-159-6477-4581wangxinyuneuron@163.com

Xiuhai Guo, MD, PhD

CONTACT

86-10-83198852guoxhxuan@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 26, 2026

First Posted

June 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)