NCT02828527

Brief Summary

Background / Rationale at. The mild head injury. In France, the incidence of head injuries is estimated at 100,000 per year in France. 80% of mild head trauma. This is a pattern of frequent use of the health system. The reason for consultation, benign appearance, present a significant risk of complication. In 15 to 25% of the evolution of head injury is unfavorable. Disorders of attention, memory disorders, psychiatric events and mood changes may occur. These symptoms are grouped into a syndrome, post-concussion syndrome. The post-concussion syndrome: It affects approximately 20,000 people per year in France. This is a common disease and most undervalued in the general population. diagnostic criteria post-concussional disorder according to DSM-IV (Diagnostic and Statistical Manual). Symptoms may persist for more than 3 months after head injury. This syndrome is responsible for suffering, personal and professional sound and quality of life of patients. It is particularly debilitating in everyday life, and can have disastrous consequences on their family, social, cultural and professional. It gives rise to many financial implications with compensation requirements and expertise consultations. Intention of work In a recent study by a team of neuropsychologists Kremlin Bicetre, it has been shown that screening and early treatment of post-concussion syndrome from the slight head injury prevents chronicity of symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

September 12, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

July 7, 2016

Last Update Submit

March 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of change in Glasgow score

    submitted between Day 0 and Day 15 and between Day 15 and Day 30

Interventions

Eligibility Criteria

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

Patients admitted to emergency Unit of Hopital Paris Saint Jospeh

You may qualify if:

  • Traumatic brain injury
  • Head injury with loss of consciousness
  • Cranio facial trauma
  • Peripheral vascular accident
  • Discomfort
  • Discomfort with loss of consciousness
  • Head trauma notion AND at least one of the following criteria:
  • Loss of consciousness \<30 minutes
  • Glasgow between 13 and 15
  • Post Traumatic Amnesia \<24H
  • Altered mental status at the time of the accident (dizziness, confusion, disorientation)
  • Transient focal neurological deficit

You may not qualify if:

  • \<18
  • Major Trust
  • Context of acute alcohol (\> 3 glasses) or toxic taking (drugs)
  • Not understanding or communication
  • Patient Refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • AÏM Jean luc, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 11, 2016

Study Start

September 12, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations