Ambulance-delivered treatment for suspected stroke

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

This study tests if giving a medication called levetiracetam and adjusting head positions to stroke patients in the ambulance can help them recover better than standard care.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2423 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai East Hospital (Academic / other)
• Locations: 2 sites (Suzhou, Anhui and 1 other locations)
• Trial ID: NCT06773364 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of administering levetiracetam and different head positions to patients with suspected acute stroke while they are still in the ambulance. It is a multicenter, randomized controlled trial involving 2323 patients across approximately 50 hospitals in China. Participants will receive either levetiracetam or standard care, and their functional outcomes will be assessed 90 days after treatment. The study aims to determine if these interventions can improve recovery outcomes for stroke patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who show symptoms of an acute stroke within 2 hours of last being well.

Not a fit: Patients who are in a coma, have severe co-morbid diseases, or have contraindications to levetiracetam will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved functional outcomes for patients experiencing acute strokes.

How similar studies have performed: While similar approaches have been explored, this specific intervention combining ambulance-delivered levetiracetam and head positioning is novel and has not been extensively tested.

Eligibility criteria

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.).

Where this trial is running

Suzhou, Anhui and 1 other locations

• Si County People's Hospital — Suzhou, Anhui, China (Recruiting)
• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Gang Li, PhD, MD — Tongji University, School of Medicine, Shanghai East Hospital
• Study coordinator: Gang Li, PhD, MD

Conditions Suspected Stroke; Ambulance; Acute stroke; Levetiracetam; Head position; intervention