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Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Sponsor: Shanghai East Hospital
Summary
This is an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. EAST aims to evaluate the effects of pre-hospital levetiracetam and different head positions initiated in ambulance settings on the functional outcome of participants assessed at 90 days.
Official title: An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2423
Start Date
2025-04-30
Completion Date
2029-12-31
Last Updated
2025-05-22
Healthy Volunteers
No
Conditions
Interventions
Levetiracetam
Intervention group - to commence IV levetiracetam 500mg as a single bolus in the ambulance, and then to continue as levetiracetam 500mg bid orally after admission to hospital in those with confirmed acute stroke for the next 14 days (at least 7 days if either dead or discharged from hospital if earlier). They will also receive standard management of acute stroke, whether the final diagnosis is ischaemic or ICH
Guide-recommended management
To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.
The lying flat (0°) head position
Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.
The sitting-up (≥30°) head position
Sit up(30-60°) - in the ambulance as soon as possible until arrival at hospital.
Locations (2)
Si County People's Hospital
Suzhou, Anhui, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China