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NCT03249129 Clinical Trial

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

Trauma Clinical Trial

— TRAME  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03249129
Other study ID # 2016_42
Secondary ID 2017-A00661-52
Status Withdrawn
Phase
First received
Last updated
Start date September 2018
Est. completion date April 2021

Study information
Verified date December 2019
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Lille

Outcome
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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