Status:
UNKNOWN
Incidence of Neurogenic Paraosteoarthropathies in a Population of Brain Traumatized and Spinal Cord Injured Patients and Specific Markers of Early NPOA Development"
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Spinal Cord Injuries
Injury, Brain, Traumatic
Eligibility:
All Genders
18+ years
Brief Summary
Neurogenic paraosteoarthropathies are peri-articular bone formations that may occur as a result of central neurological injury. Their occurrence limits reeducation and recovery capacities. Neurogenic ...
Detailed Description
Based on the results of collaborative and translational (human-animal) work, investigators wish to conduct the first prospective study that would allow: (i) To assess the incidence of Neurogenic para...
Eligibility Criteria
Inclusion
- Male or Female \> 18 years old,
- brain trauma with initial Glasgow score \< 8,
- or brain trauma with an initial Glasgow score between 8 and 14 associated with an Injury Severity Score (ISS) \> 15 and surgery within 24 hours of admission or traumatic spinal cord injury with complete neurological impairment (initial para/tetraplegia),
- Complete traumatic spinal cord injury. Accident less than 48 hours old
- Informed consent signed by the patient or a family member
Exclusion
- Age \< 18 years,
- Hemorrhagic shock or blood transfusion greater than or equal to 4 red blood cells within 6 hours of the trauma (also include pre-hospital or first hospital red blood cells)
- Follow-up impossible over one year,
- Patient not living in the Paris region,
- Pregnant or breastfeeding woman,
- Patient under guardianship or curatorship,
- No affiliation to a social security scheme or universal mutual fund.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2024
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04273347
Start Date
September 15 2023
End Date
December 15 2024
Last Update
August 31 2023
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