Suspected Stroke
Conditions
Keywords
Ambulance, Acute stroke, Levetiracetam, Head position, intervention
Brief 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.
Detailed description
EAST is a multicenter, ambulance-delivered, prospective, randomized controlled, open label blinded outcome assessment (PROBE) study to be conducted through a regional-cluster hospital network of investigators. A total of 2323 patients with suspected acute stroke will be recruited from approximately 50 hospitals in China. Potentially eligible patients will be recruited into the study by either of two mechanisms: (1) waver of consent to the intervention, and consent to follow-up obtained in hospital; or (ii) consent to the intervention through a brief written consent which is combined with a usual care consent form delivered in hospital for follow-up (if a waver of consent is not approved by the ethics committee). All patients will enter Part A and Part B at the same time, randomised allocation of intervention will be done in a 1:1 ratio in each part, using a central, automated, mobile phone Wechat mini program-based electronic randomization software according to minimization method stratified by ambulance systems, age (≥65 vs \<65) and FAST(\>2 vs =2). The intervention of Part A is to commence IV levetiracetam(LEV) 500mg as a single bolus in the ambulance and then to continue as LEV 500mg Bid orally after hospital admission for 14 days(at least 7 days if discharged or death early), compared to avoid prophylactic use of antiseizure drugs. Part B is to lie flat or sit up in the ambulance as soon as possible until hospital arrival. Ambulance staff will be well trained across the whole study to master mobile randomisation and simple key data collection. All information in ambulance, including basic demographics, randomised allocation, BP measurement and treatment details, will be collected through mobile phone based electronic database system connected with investigator clinicians in hospitals. Other relevant documents such as consent paper, BP chart will be handed over to hospital investigators. Endpoint assessment will be blinded to treatment allocation.
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.
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional shift (improvement) in 7-level mRS scores | 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| health related quality of life on the EQ-5D-5L | 90 days | — |
| severe disability (mRS 3-5) | 90 days | — |
| death and/or severe disability (mRS 3-6) | 90 days | — |
| utility-weighted-mRS (UW-mRS) | 90 days | — |
| neurological severity on the National Institute of Health stroke scale (NIHSS) | 24 hours from randomization | 0-42, higher scores indicates worse severity |
| living circumstances questions | 90 days | living at home \[the individual's own or that of a family member\] or living at an institution(hospital, care facility, or other) |
| any seizures during follow-up | 90 days, 6 months, 12 months | assessed by 6 screening questions modified from the Canadian Longitudinal Study on Aging-Epilepsy Algorithm (CLSA-EA) |
| haematoma volume | at hospital admission and 24 hours | in patients with final diagnosis of ICH |
| Hematoma expansion | 24 hours | in patients with final diagnosis of ICH |
| proportion of hospital discharge at Day 7 | 7 days | — |
Countries
China
Contacts
Primary ContactGang Li, PhD, MD
Backup ContactChen Chen, PhD, MD
Outcome results
None listed