SeizuresBISTRONCT01774500
Biomarkers In Seizure To Predict Recurrence and Severe Outcomes
An observational study of Seizures and S-100b Protein, run by Bistro Study Group at 4 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seizures, S-100b Protein, Copeptin
- How many people
- 300 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2013to Mar 2014
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patients
Who may be able to join
- Seizure within 24 hours of ED attendance
- Or Seizure in the ED
Who cannot join
- Pregnancy
- Prisoner
- age < 18 years old
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
Hopital Lariboisiere
Paris, 75010
Groupe Hospitalier pitie-salpetriere
Paris, 75013
Hopital Tenon
Paris, 75020
United Kingdom1 site
Royal London Hospital, Barts Health NHS Trust
London, E1 1BB
About this study
Official title: 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
Read the 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
- Conditions
- Seizures, S-100b Protein, Copeptin
- Keywords
- biomarkers, Emergency Department, Seizures, epilepsy, S100b, copeptin
- Medical subject headings
- Seizures, Diabetes Insipidus, Emergencies, Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined hospital admission, seizure recurrence, or death at day 7
Measured: 7 days
Secondary outcomes (5)
Hospital free days
number of days out of hospital, death corresponding to 0
Measured: 7 days
Hospital free days
Measured: day 28
death or ICU admission
Measured: day 7
Death or ICU admission
Measured: 28 days
Recurrence of seizure
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bistro Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Barts & The London NHS Trust
- Responsible party
- Principal investigator, Yonathan Freund, Bistro Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774500
- Sponsor's protocol ID
- BISTRO
- Acronym
- BISTRO
- Status last verified
- Mar 2014
- First submitted
- 22 Jan 2013
- Last updated
- 27 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prognosis Value of Protein S100Beta and Copeptine in Seizure in the Emergency Department
- ClinicalTrials.gov ID
- NCT01774500
- Acronym / sponsor ID
- BISTRO / BISTRO
- Conditions
- Seizures, S-100b Protein, Copeptin
- Keywords
- biomarkers, Emergency Department, Seizures, epilepsy, S100b, copeptin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bistro Study GroupUniversity, hospital or other
- Collaborators
- Groupe Hospitalier Pitie-Salpetriere, Barts & The London NHS Trust
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients
Key inclusion criteria (2 listed)
- Seizure within 24 hours of ED attendance
- Or Seizure in the ED
Key exclusion criteria (3 listed)
- Pregnancy
- Prisoner
- age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined hospital admission, seizure recurrence, or death at day 7
Time frame: 7 days
5 secondary outcomes
Hospital free days
Time frame: 7 days
Hospital free days
Time frame: day 28
death or ICU admission
Time frame: day 7
Death or ICU admission
Time frame: 28 days
Recurrence of seizure
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and S-100b Protein, run by Bistro Study Group at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined hospital admission, seizure recurrence, or death at day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.