NCT01774500

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 27, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

January 22, 2013

Last Update Submit

March 26, 2014

Conditions

SeizuresS-100b ProteinCopeptin

Keywords

biomarkersEmergency DepartmentSeizuresepilepsyS100bcopeptin

Outcome Measures

Primary Outcomes (1)

  • Combined hospital admission, seizure recurrence, or death at day 7

    7 days

Secondary Outcomes (5)

  • Hospital free days

    7 days

  • Hospital free days

    day 28

  • death or ICU admission

    day 7

  • Death or ICU admission

    28 days

  • Recurrence of seizure

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency department patients

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Prisoner
  • age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hopital Lariboisiere

Paris, 75010, France

Location

Groupe Hospitalier pitie-salpetriere

Paris, 75013, France

Location

Hopital Tenon

Paris, 75020, France

Location

Royal London Hospital, Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 5ml serum sample for proteine S100Beta and copeptine analysis

MeSH Terms

Conditions

SeizuresDiabetes InsipidusEmergenciesEpilepsy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesBrain DiseasesCentral Nervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef de Clinique - Research fellow. MD

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

March 1, 2014

Last Updated

March 27, 2014

Record last verified: 2014-03

Locations

FR(3)GB(1)