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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01774500

Acronym

BISTRO

Enrollment

300

Registered

2013-01-24

Start date

2013-01-31

Completion date

2014-03-31

Last updated

2014-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copeptin, S-100b Protein, Seizures

Keywords

biomarkers, Emergency Department, Seizures, epilepsy, S100b, copeptin

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Seizure within 24 hours of ED attendance * Or Seizure in the ED

Exclusion criteria

* Pregnancy * Prisoner * age \< 18 years old

Design outcomes

Primary

Measure	Time frame
Combined hospital admission, seizure recurrence, or death at day 7	7 days

Secondary

Measure	Time frame	Description
Hospital free days	7 days	number of days out of hospital, death corresponding to 0
death or ICU admission	day 7	—
Death or ICU admission	28 days	—
Recurrence of seizure	7 days	—

Countries

France, United Kingdom

Outcome results