Care Courses for Mild Head Injury Patients
1 other identifier
observational
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
September 12, 2014
CompletedFirst Submitted
Initial submission to the registry
July 7, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMarch 14, 2018
March 1, 2018
3.3 years
July 7, 2016
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
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
AÏM Jean luc, MD
Fondation Hôpital Saint-Joseph
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