NCT04147663

Brief Summary

The occurrence of isolated or recurring epileptic seizures accounts for an important use of the healthcare system. Typically, epileptic patient will consult ten times a year a physician (specialist or familial doctor) and will justify 24 diagnostic procedures or additional examinations. Moreover, epileptic seizures are associated with frequent use of emergency departments. From the first emergency call received by the Emergency medical assistance service (SAMU), the actual management of the patient having epileptic seizure includes the eventual transfer to the paramedical team then within an emergency unit. However in some cases, emergency allocation may be avoided as 70% of patients recover their baseline condition upon admission. The main objective of this study is to describe the management of the adult population suffering from suspected seizure by the emergency structures. For 3 consecutive days, all patients with suspected epileptic seizures (diagnosed by the SAMU, paramedics and emergency unit) will be enrolled in the study. Data of medical care management and information from patients or witnesses will be collected on a questionnaire by the physicians of the SAMU, paramedics and emergency unit. Then, the anonymized questionnaires will be sent to RESUVAL (Emergency Network of the Rhone Valley) to ensure data entry and statistical analysis. By identifying the factors leading the SAMU to transfer a patient with suspected epileptic seizure to an emergency unit, this study will provide a more appropriate procedure to prevent unnecessary emergency admissions. It will also gain more insights into the patient outcomes, such as complementary medication, brain examination or referral to a neurologist.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

December 26, 2019

Status Verified

December 1, 2019

Enrollment Period

Same day

First QC Date

October 30, 2019

Last Update Submit

December 24, 2019

Conditions

Keywords

emergencyepileptic seizureepilepsyneurology

Outcome Measures

Primary Outcomes (1)

  • Description of the management of the adult population suffering from suspected seizure by the emergency structures.

    The patient journey will be followed from the call to the emergency medical assistance service (SAMU) with a possible transfer by the paramedical team until the care, within the emergency unit.

    3 days

Secondary Outcomes (1)

  • The patient characteristics, treatment pathway and outcomes after discharge

    11 days

Interventions

For 3 consecutive days, all patients with suspected epileptic seizures (assessed by the Emergency medical assistance service ( SAMU), paramedical team and the emergency unit) will be included in the study. With the use of questionnaries, information will be collected from patients or witnesses by the SAMU, the paramedical team or physicians of the emergency unit. A 7-day follow-up will be carried out by the principal investigator (PI) of each center.

Eligibility Criteria

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

Any patient ≥18 years calling the Emergency medical assistance service (SAMU)

You may qualify if:

  • Any patient ≥18 years calling the SAMU and / or supported by a paramedical team and / or admitted to an emergency unit for suspected symptoms of epileptic seizure will be included.
  • SAMU=Emergency medical assistance service

You may not qualify if:

  • Patients with no epileptic seizures (assessed by the SAMU, paramedical team and the emergency unit) can't be enrolled in the study.
  • SAMU=Emergency medical assistance service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier St Joseph St Luc

Lyon, 69007, France

Location

MeSH Terms

Conditions

EpilepsyEmergenciesSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sylvie MEYRAN, MD

    Centre Hospitalier Saint Joseph St Luc de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 1, 2019

Study Start

October 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

December 26, 2019

Record last verified: 2019-12

Locations