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

B

Bistro Study Group

Status

Completed

Conditions

Seizures
Copeptin
S-100b Protein

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Prisoner
  • age < 18 years old

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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