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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Xuanwu Hospital, Beijing
- Enrollment
- 706
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Glasgow Coma Scale (GCS) score ≤
- •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.
Investigators
Xiuhai Guo,MD
Principal Investigator
Xuanwu Hospital, Beijing