Biomarkers In Seizure To Predict Recurrence and Severe Outcomes (BISTRO)
This study is currently recruiting participants.
Verified January 2013 by Bistro Study Group
Sponsor:
Bistro Study Group
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: January 31, 2013
Last verified: January 2013
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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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
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 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774500
Contacts
| Contact: Yonathan Freund, MD | 0044 7706002709 | yonathanfreund@gmail.com |
| Contact: bruno Riou, MD, PhD | bruno.riou@psl.aphp.fr |
Locations
| France | |
| Groupe Hospitalier pitie-salpetriere | Recruiting |
| Paris, France, 75013 | |
| Contact: Pierre Hausfater, MD,PhD pierre.hausfater@psl.aphp.fr | |
| Principal Investigator: Pierre Hausfater, MD, PhD | |
| Hopital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact: Patrick ray, MD,PhD patrick.ray@tnn.aphp.fr | |
| Principal Investigator: nacera baarir, MD | |
| Hopital Lariboisiere | Recruiting |
| Paris, France, 75010 | |
| Contact: Said laribi, MD said.laribi@lrb.aphp.fr | |
| Principal Investigator: Said Laribi, MD | |
| United Kingdom | |
| Royal London Hospital, Barts Health NHS Trust | Recruiting |
| London, United Kingdom, E1 1BB | |
| Contact: Yonathan Freund, MD 00447706002709 yonathanfreund@gmail.com | |
| Contact: Benjamin Bloom, MD | |
| Principal Investigator: Rupert Pearse, MD, PhD | |
| Sub-Investigator: Benjamin Bloom, MD | |
| Sub-Investigator: Yonathan Freund, MD | |
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: | January 31, 2013 |
| 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 Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013