Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

Seizures Clinical Trial

— BISTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774500
• Other study ID #: BISTRO
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: March 26, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Bistro Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : comite for Protection of personnesUnited Kingdom : Research Ethics comitee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Seizure within 24 hours of ED attendance

• Or Seizure in the ED

Exclusion Criteria:

• Pregnancy

• Prisoner

• age < 18 years old

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Copeptin
• S-100b Protein
• Seizures

Locations

Country	Name	City	State
France	Groupe Hospitalier pitie-salpetriere	Paris
France	Hopital Lariboisiere	Paris
France	Hopital Tenon	Paris
United Kingdom	Royal London Hospital, Barts Health NHS Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
Bistro Study Group	Barts & The London NHS Trust, Groupe Hospitalier Pitie-Salpetriere

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined hospital admission, seizure recurrence, or death at day 7		7 days	No
Secondary	Hospital free days	number of days out of hospital, death corresponding to 0	7 days	No
Secondary	Hospital free days		day 28	No
Secondary	death or ICU admission		day 7	No
Secondary	Death or ICU admission		28 days	No
Secondary	Recurrence of seizure		7 days	No