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Completed

NCT Number: NCT01774500

Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

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

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Key information

Conditions

Seizures Brain Diseases Central Nervous System Diseases Copeptin Diabetes Insipidus Disease Attributes Emergencies Endocrine System Diseases Epilepsy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases S-100b Protein Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier pitie-salpetriere, Paris, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Prisoner
  • age < 18 years old

Treatment and study plan

Primary outcomes

  1. Combined hospital admission, seizure recurrence, or death at day 7

    Time frame: 7 days

Secondary outcomes

  1. Hospital free days

    Time frame: 7 days

    number of days out of hospital, death corresponding to 0

  2. Hospital free days

    Time frame: day 28

  3. death or ICU admission

    Time frame: day 7

  4. Death or ICU admission

    Time frame: 28 days

  5. Recurrence of seizure

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Bistro Study Group

Other

Collaborators

  • Barts & The London NHS Trust
  • Groupe Hospitalier Pitie-Salpetriere

Registry information

Official study title

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

Acronym: BISTRO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2013
Registry last updated
Mar 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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