Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249129
Recruitment Status : Withdrawn (sponsor decision)
First Posted : August 15, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Bone Marrow Failure Trauma

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Level of anti glial fibrillary acid protein antibodies [ Time Frame: 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 :
  1. Blood level of anti glial fibrillary acid protein antibodies [ Time Frame: 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

  2. Severity of Neurological Impairment [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249129


Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Fahed Zairi, MD University Hospital, Lille
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03249129    
Other Study ID Numbers: 2016_42
2017-A00661-52 ( Other Identifier: ID-RCB number, ANSM )
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Trauma
spinal cord
autoimmunity
antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Pancytopenia
Wounds and Injuries
Hematologic Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System