NCT01774500

Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Bistro Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

Detailed description

Prospective study for a 12 month period in Paris (France) and London (UK). Inclusion criteria : * seizure within 24h of attendance to an Emergency department (ED) * or seizure in the ED Exclusion Criterie : * pregnancy * prisoneer Primary endpoint : \- recurrence of seizure, hospitalisation more than 24 hours or death within seven days Secondary endpoint : * Hospital free days at day 7 and day 28 * Death, ICU admission, or neurosurgical intervention at day 7 and day 28 * Return visit to the ED or re admission at day 7 and day 28 data collection: * demographics * past medical history, medication * vital signs (Heart rate, temperature, Pulse oxymetry, blood pressure, GCS) on arrival * Pathology (White cell count, Sodium, Calcium, Glucose, lactate) * Protein S100B and Copeptin * Seizure characteristics (Witnessed, simple, partial, complex, provoked, acute symptomatic, idiopathic) * Discharge plan, outcomes Follow up at day 7 and day 28, hospital visit or phone call

Conditions

• Seizures
• S-100b Protein
• Copeptin

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-01-01
• Completion: 2014-03-01
• First posted: 2013-01-24
• Last updated: 2014-03-27

Locations

4 sites across 2 countries: France, United Kingdom