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Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial

RecruitingPhase 3Ages 18 Years - anyAllShanghai East Hospital
NCT06773364 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults (age ≥18 years); * Acute condition that is presumed due to acute stroke, defined on the FAST (Face, Arm, Speech, Time) screen (score ≥2 with an arm deficit); * Time ≤2 hours from last seen well; * Able to provide brief consent (if a waver of consent not approved by ethics committee). Exclusion Criteria: * coma (no response to painful stimulation); * severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability \[needing help with everyday activities\]); * history of epilepsy or seizure at onset; * recent head injury; * hypoglycaemia (glucose \<2.8mmol/L); * clear indications or contraindications (allergies) for levetiracetam; * lactating women; * clear indications for a particular head position or situations where either head position cannot be maintained (such as severe vomiting and inability to lie down, severe obesity with fatigue and difficulty sitting up, etc.).
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What it tests

  • Levetiracetam
  • Guide-recommended management
  • The lying flat (0°) head position
  • The sitting-up (≥30°) head position
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Where

2 sites
Si County People's Hospital
Suzhou, China
Shanghai East Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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