Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
ConditionSuspected Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai East Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Levetiracetam
- Guide-recommended management
- The lying flat (0°) head position
- The sitting-up (≥30°) head position
Treatment groups
2,423 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov