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

Launched by SHANGHAI EAST HOSPITAL · Jan 13, 2025

Keywords

ClinConnect Summary

The Early Initiated Ambulance-delivered Levetiracetam and Headposition in Hyper-acute Stroke Trial is a research study looking at how certain treatments given in an ambulance can improve outcomes for people suspected of having a stroke. Specifically, the study will test a medication called levetiracetam and different head positions to see if they can help patients recover better after a stroke. Researchers will evaluate the effects of these treatments on participants' health 90 days after their stroke symptoms begin.

To be eligible for this study, participants need to be at least 18 years old and show clear signs of a stroke based on a simple screening test. They must also arrive at the hospital within two hours of last being well. However, individuals with certain serious health issues, a history of seizures, or other specific conditions may not be able to participate. If you join the study, you can expect to receive care in an ambulance that includes the trial treatments, and you will be followed up to see how well you are doing after three months. This trial is not yet recruiting participants, but it aims to provide important information about stroke treatment in emergency situations.

Gender

ALL

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.).