Biomarkers In Seizure To Predict Recurrence and Severe Outcomes — BISTRO  

Seizures Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Copeptin
• S-100b Protein
• Seizures

• NCT number: NCT01774500
• Study type: Observational [Patient Registry]
• Source: Bistro Study Group
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: March 2014