Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

NCT ID: NCT01774500

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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

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Seizures S-100b Protein Copeptin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy
* Prisoner
* age \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role collaborator

Bistro Study Group

OTHER

Sponsor Role lead

Responsible Party

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Yonathan Freund

Chef de Clinique - Research fellow. MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hopital Lariboisiere

Paris, , France

Site Status

Groupe Hospitalier pitie-salpetriere

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Royal London Hospital, Barts Health NHS Trust

London, , United Kingdom

Site Status

Countries

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France United Kingdom

Other Identifiers

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BISTRO

Identifier Type: -

Identifier Source: org_study_id

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