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WithdrawnNCT03249129TRAMEUpdated Dec 5, 2019

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

An observational study in Bone Marrow Failure and Trauma, sponsored by University Hospital, Lille. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by University Hospital, Lille · Observational

Why this study was withdrawn
sponsor decision
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Bone Marrow Failure
  • Trauma

Keywords

  • Trauma
  • spinal cord
  • autoimmunity
  • antibody
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Level of anti glial fibrillary acid protein antibodies

    Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid

    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.

Secondary outcomes

  1. Blood level of anti glial fibrillary acid protein antibodies

    Anti glial fibrillary acid protein antibodies measured into the blood

    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.

  2. Severity of Neurological Impairment

    Measured using the American Society Injury Association score

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03249129
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Aug 15, 2017
Start date
Sep 2018 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Dec 5, 2019

Study contacts

Fahed Zairi, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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