Cardiovascular Diseases, Cerebral Hemorrhage, Cerebral Hemorrhage, Hypertensive, Cerebrovascular Disorders, Hemorrhage, Hemorrhagic Stroke, Intracerebral, Intracranial Hemorrhages, Nervous System Diseases, Stroke, Vascular Diseases
Conditions
Keywords
intracerebral hemorrhage, mobile stroke units, Intensive blood pressure lowering
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.
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.
Interventions
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.
OTHERStandard 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
Xuanwu Hospital, Beijing
Beijing Emergency Medical Center
Huizhou Third People's Hospital, Guangzhou Medical University
Suzhou First People's Hospital
Nanyang nanshi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of no or moderate disability | 90 ± 7 days | defined by mRS 0-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma volume | 24±6 hours | evaluated by CT |
| Modified Rankin Scale (mRS) score | 90 ± 7 days | the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death) |
| Proportion of without severe disability | 90±7 days | defined by mRS0-4 |
| National Institutes of Health Stroke Scale (NIHSS) score | 24 ± 6 hours and 7 ± 1 days | 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. |
| In-hospital mortality rate | 7 ±1 days /discharge | Frequency of patients dying within the duration of the hospital stay after admission for stroke |
| All-cause mortality rate | 90±7 days | — |
| Proportion of surgical interventions | Within 7±1 days | Interventions include hematoma evacuation, external ventricular drainage, and craniectomy. |
| Incidence of severe hypotension events | 24±12 hours, 7±1 days | Hypotension with clinical consequences (including acute renal failure) that required corrective therapy with intravenous fluids, vasopressors, or hemodialysis. |
| Health-related quality of life | 90±7 days | 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. |
Countries
China
Contacts
CONTACTXinyu Wang, MD
CONTACTXiuhai Guo, MD, PhD
Outcome results
None listed