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RecruitingPhase 3NCT06773364

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

An Investigator Initiated and Conducted, Prospective, Multicentre, Randomised Outcome-blinded Study of Pre-hospital Initiated Levetiracetam and Headposition in Patients With Presumed Acute Stroke

Sponsor

Shanghai East Hospital

Enrollment

2,423 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Suspected Stroke

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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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Interventions

DRUGLevetiracetam

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

OTHERGuide-recommended management

To receive stroke management according to standard local guidelines, but to avoid prophylactic use of an anti-seizure drug.

OTHERThe lying flat (0°) head position

Lie flat (0°) - in the ambulance as soon as possible until arrival at hospital.

OTHERThe 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

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NCT06773364