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

Brief Title

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

Official Title

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

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.
    



Study Type

Observational


Primary Outcome

Level of anti glial fibrillary acid protein antibodies

Secondary Outcome

 Blood level of anti glial fibrillary acid protein antibodies

Condition

Bone Marrow Failure



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

0

Start Date

September 2018

Completion Date

April 2021

Primary Completion Date

April 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Fahed Zairi, MD, , 



Administrative Informations


NCT ID

NCT03249129

Organization ID

2016_42

Secondary IDs

2017-A00661-52

Responsible Party

Sponsor

Study Sponsor

University Hospital, Lille


Study Sponsor

Fahed Zairi, MD, Principal Investigator, University Hospital, Lille


Verification Date

December 2019