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

This study has been completed.
Sponsor:
Collaborators:
Groupe Hospitalier Pitie-Salpetriere
Barts & The London NHS Trust
Information provided by (Responsible Party):
Yonathan Freund, Bistro Study Group
ClinicalTrials.gov Identifier:
NCT01774500
First received: January 22, 2013
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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
Seizures
S-100b Protein
Copeptin

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department

Resource links provided by NLM:


Further study details as provided by Bistro Study Group:

Primary Outcome Measures:
  • Combined hospital admission, seizure recurrence, or death at day 7 [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital free days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    number of days out of hospital, death corresponding to 0

  • Hospital free days [ Time Frame: day 28 ] [ Designated as safety issue: No ]
  • death or ICU admission [ Time Frame: day 7 ] [ Designated as safety issue: No ]
  • Death or ICU admission [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Recurrence of seizure [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

2 5ml serum sample for proteine S100Beta and copeptine analysis


Estimated Enrollment: 300
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Emergency department patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774500

Locations
France
Groupe Hospitalier pitie-salpetriere
Paris, France, 75013
Hopital Lariboisiere
Paris, France, 75010
Hopital Tenon
Paris, France, 75020
United Kingdom
Royal London Hospital, Barts Health NHS Trust
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Bistro Study Group
Groupe Hospitalier Pitie-Salpetriere
Barts & The London NHS Trust
  More Information

No publications provided

Responsible Party: Yonathan Freund, Chef de Clinique - Research fellow. MD, Bistro Study Group
ClinicalTrials.gov Identifier: NCT01774500     History of Changes
Other Study ID Numbers: BISTRO
Study First Received: January 22, 2013
Last Updated: March 26, 2014
Health Authority: France : comite for Protection of personnes
United Kingdom : Research Ethics comitee

Keywords provided by Bistro Study Group:
biomarkers
Emergency Department
Seizures
epilepsy
S100b
copeptin

Additional relevant MeSH terms:
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsy
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014