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

December 3, 2019 updated by: University Hospital, Lille

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 Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_42
  • 2017-A00661-52 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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