BISTRO: Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

Sponsor

Bistro Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT01774500

Collaborator

Groupe Hospitalier Pitie-Salpetriere (Other), Barts & The London NHS Trust (Other)

300

Enrollment

Locations

13.9

Duration (Months)

Patients Per Site

5.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Seizures S-100b Protein Copeptin

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

Combined hospital admission, seizure recurrence, or death at day 7 [7 days]

Secondary Outcome Measures

Hospital free days [7 days]
number of days out of hospital, death corresponding to 0
Hospital free days [day 28]
death or ICU admission [day 7]
Death or ICU admission [28 days]
Recurrence of seizure [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Prisoner
age < 18 years old

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hopital Lariboisiere	Paris	France	75010
2	Groupe Hospitalier pitie-salpetriere	Paris	France	75013
3	Hopital Tenon	Paris	France	75020
4	Royal London Hospital, Barts Health NHS Trust	London	United Kingdom	E1 1BB