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

Withdrawn

• Conditions: Trauma; Bone Marrow Failure

• Registration Number: NCT03249129
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-15
• Study Start: 2018-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-05
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid

Secondary Outcome Measures

Name	Time	Method
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.	Anti glial fibrillary acid protein antibodies measured into the blood
Severity of Neurological Impairment	in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year	Measured using the American Society Injury Association score