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Clinical Trials/NCT01774500
NCT01774500
Completed
Not Applicable

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

Bistro Study Group4 sites in 2 countries300 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Seizures
Sponsor
Bistro Study Group
Enrollment
300
Locations
4
Primary Endpoint
Combined hospital admission, seizure recurrence, or death at day 7
Status
Completed
Last Updated
12 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
March 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bistro Study Group
Responsible Party
Principal Investigator
Principal Investigator

Yonathan Freund

Chef de Clinique - Research fellow. MD

Bistro Study Group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnancy
  • age \< 18 years old

Outcomes

Primary Outcomes

Combined hospital admission, seizure recurrence, or death at day 7

Time Frame: 7 days

Secondary Outcomes

  • Death or ICU admission(28 days)
  • death or ICU admission(day 7)
  • Hospital free days(day 28)
  • Recurrence of seizure(7 days)

Study Sites (4)

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