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

NCT03249129 | Withdrawn

• 2 other identifiers: 2016_422017-A00661-52
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Marrow Failure; Trauma

Keywords

Trauma; spinal cord; autoimmunity; antibody

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Blood level of anti glial fibrillary acid protein antibodies

  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.

• Severity of Neurological Impairment

  in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients over 18 years old with spinal cord trauma, for whom CSF sampling may be performed safely within the first 48 hours.

You may qualify if:

• Patients with spinal cord injury dating back less than 48 hours
• Men or women over 18 years of age
• Patients benefiting from social protection
• Surgery performed within 48 hours of the trauma
• Informed and signed consent by the patient or trusted person

You may not qualify if:

• Contra-indication to ensure surgical decompression within the first 48 hours following the trauma
• Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery)
• Severe cranial trauma associated
• History of autoimmune pathology
• Immunosuppressive therapy or long-term corticosteroid therapy
• Patients unable to comply with protocol requirements
• Person benefiting from legal protection (guardianship / curator)
• Person deprived of liberty
• Patient unable to express consent
• Pregnant women

Sponsors & Collaborators

• University Hospital, Lille: lead

MeSH Terms

Conditions

Bone Marrow Failure Disorders; Wounds and Injuries; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Fahed Zairi, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share