Mild Head Injury Clinical Trial
Official title:
Care Courses for Mild Head Injury Patients
Verified date | March 2018 |
Source | Groupe Hospitalier Paris Saint Joseph |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Before Inclusion Criteria: - Traumatic brain injury - Head injury with loss of consciousness - Cranio facial trauma - Peripheral vascular accident - Discomfort - Discomfort with loss of consciousness Before Inclusion Criteria: - 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 Exclusion Criteria: - <18 - Major Trust - Context of acute alcohol (> 3 glasses) or toxic taking (drugs) - Not understanding or communication - Patient Refusal |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Paris Saint Joseph | Paris | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Paris Saint Joseph |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of change in Glasgow score | submitted between Day 0 and Day 15 and between Day 15 and Day 30 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04305821 -
Medico-economic Interest of the Protein S100b in Mild Head Trauma Under Anti-thrombotics
|