Actively Recruiting
Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Led by Shanghai East Hospital · Updated on 2025-05-22
2423
Participants Needed
2
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Acute condition presumed due to acute stroke with a FAST score of 2 or more including an arm deficit
- Time from last seen well is 2 hours or less
- Able to provide brief consent if waiver of consent is not approved by ethics committee
You will not qualify if you...
- Coma with no response to painful stimulation
- Severe co-morbid diseases such as cancer, chronic airflow disease, severe dementia, severe heart failure, or pre-existing disability needing help with everyday activities
- History of epilepsy or seizure at stroke onset
- Recent head injury
- Hypoglycaemia with glucose less than 2.8 mmol/L
- Clear indications or contraindications (allergies) for levetiracetam
- Lactating women
- Clear indications for a particular head position or inability to maintain head position due to conditions like severe vomiting, inability to lie down, severe obesity with fatigue, or difficulty sitting up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Si County People's Hospital
Suzhou, Anhui, China, 234399
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
G
Gang Li, PhD, MD
CONTACT
C
Chen Chen, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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