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Clinical Trials/NCT01774500
NCT01774500CompletedNot Applicable

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

Bistro Study Group4 sites in 2 countries300 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
4
Primary Endpoint
Combined hospital admission, seizure recurrence, or death at day 7

Study 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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Bistro Study Group
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yonathan Freund

Chef de Clinique - Research fellow. MD

Bistro Study Group

Study Sites (4)

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