Biomarkers In Seizure To Predict Recurrence and Severe Outcomes (BISTRO)

March 26, 2014 updated by: Yonathan Freund, Bistro Study Group

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75020
        • Hopital Tenon
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
  • United Kingdom
      • London, United Kingdom, E1 1BB
        • Royal London Hospital, Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Emergency department patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Prisoner
  • age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined hospital admission, seizure recurrence, or death at day 7
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital free days
Time Frame: 7 days
number of days out of hospital, death corresponding to 0
7 days
Hospital free days
Time Frame: day 28
day 28
death or ICU admission
Time Frame: day 7
day 7
Death or ICU admission
Time Frame: 28 days
28 days
Recurrence of seizure
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bistro Study Group

Collaborators

Barts & The London NHS Trust
Groupe Hospitalier Pitie-Salpetriere

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BISTRO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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