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Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma

Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03249129
Acronym
TRAME
Enrollment
0
Registered
2017-08-15
Start date
2018-09-30
Completion date
2021-04-30
Last updated
2019-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Failure, Trauma

Keywords

Trauma, spinal cord, autoimmunity, antibody

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of anti glial fibrillary acid protein antibodiesThe 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.Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid

Secondary

MeasureTime frameDescription
Blood level of anti glial fibrillary acid protein antibodiesThe 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.Anti glial fibrillary acid protein antibodies measured into the blood
Severity of Neurological Impairmentin the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 yearMeasured using the American Society Injury Association score

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026