Ambulance-delivered treatment for suspected stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ligang@tongji.edu.cn
• Phone: 86 13621691786

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.