ClinicalTrials.gg
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 Withdrawn.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Why this study was withdrawn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
01

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.

02

Conditions studied

  • Bone Marrow Failure
  • Trauma

Keywords

  • Trauma
  • spinal cord
  • autoimmunity
  • antibody
03

In context

Bone Marrow Failure Disorders

91 studies on the registry are indexed under Bone Marrow Failure Disorders; 29 are open to participants now.

Browse Bone Marrow Failure Disorders studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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 pathology
  5. therapy or long-term 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
06

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2018; primary completion for Apr 2021, 31 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2017
First posted
Aug 15, 2017
StartEst.
Sep 2018
Primary completionEst.
Apr 2021
CompletionEst.
Apr 2021
Last update
Dec 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03249129
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion