Status:
COMPLETED
Efficacy of Multidimensional Management of Mild Traumatic Brain Injury
Lead Sponsor:
Institut de Recherche sur la Moelle épinière et l'Encéphale
Conditions:
Mild Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Unfavorable outcomes (UO) are seen in 15 to 20% of patients with mild traumatic brain injury (mTBI). Early identification of patients at risk for UO is crucial for suitable management to be initiated,...
Eligibility Criteria
Inclusion
- \- Patients aged 18 to 65 who have suffered mTBI, have health care coverage, who understand French, who can be followed for 6 months, and who are able to understand, reply, and cooperate.
Exclusion
- Patient intubated and/or ventilated and/or sedated upon arrival at hospital
- Patient with injury to the medulla and with neurological signs or multiple injuries (at least 1 of which is life-threatening)
- Brain injury incurred during a suicide attempt
- Patient presenting psychiatric or psychological disorders that are debilitating and/or interfere with follow-up and/or evaluation
- Psychoactive treatment ongoing at the time of injury
- History of hospitalization in specialized a psychiatric setting and/or sick leave for psychological reasons
- Patient with a neurological disorder
- Patient with substance dependence
- Subject under guardianship or wardship
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2013
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT03811626
Start Date
April 1 2012
End Date
June 30 2013
Last Update
January 24 2019
Active Locations (6)
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1
Chu Bicetre
Le Kremlin-Bicêtre, France
2
Chu Montpellier
Montpellier, France
3
Chu Bichat/Beaujon
Paris, France
4
CHU St ANTOINE
Paris, France