Trauma Clinical Trial
— TRAMEOfficial title:
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Verified date | December 2019 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the study is to detect the presence of autoantibodies and autoantigens in
cerebrospinal fluid early (<48 hours) following spinal cord trauma.
The study also aims to define the central or peripheral origin of autoantibodies by looking
for their simultaneous presence at the blood level and to evaluate the prognostic value of
the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial
clinical severity than on the recovery potential.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with spinal cord injury dating back less than 48 hours 2. Men or women over 18 years of age 3. Patients benefiting from social protection 4. Surgery performed within 48 hours of the trauma 5. Informed and signed consent by the patient or trusted person Exclusion Criteria: 1. Contra-indication to ensure surgical decompression within the first 48 hours following the trauma 2. Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery) 3. Severe cranial trauma associated 4. History of autoimmune pathology 5. Immunosuppressive therapy or long-term corticosteroid therapy 6. Patients unable to comply with protocol requirements 7. Person benefiting from legal protection (guardianship / curator) 8. Person deprived of liberty 9. Patient unable to express consent 10. Pregnant women |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of anti glial fibrillary acid protein antibodies | Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid | The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours. | |
Secondary | Blood level of anti glial fibrillary acid protein antibodies | Anti glial fibrillary acid protein antibodies measured into the blood | The sampling is performed at the initial stage, i.e. within 48 hours after trauma. The time between trauma and sampling is specified and measured in hours. | |
Secondary | Severity of Neurological Impairment | Measured using the American Society Injury Association score | in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year |
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