Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

Completed

• Conditions: Copeptin; S-100b Protein; Seizures

• Registration Number: NCT01774500
• Lead Sponsor: Bistro Study Group

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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2014-01
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Prisoner
• age < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined hospital admission, seizure recurrence, or death at day 7	7 days

Secondary Outcome Measures

Name	Time	Method
Death or ICU admission	28 days
death or ICU admission	day 7
Hospital free days	day 28
Recurrence of seizure	7 days

Trial Locations

Locations (4)

Hopital Lariboisiere; 🇫🇷 Paris, France

Groupe Hospitalier pitie-salpetriere; 🇫🇷 Paris, France

Hopital Tenon; 🇫🇷 Paris, France

Royal London Hospital, Barts Health NHS Trust; 🇬🇧 London, United Kingdom