Bone Marrow FailureTRAMENCT03249129
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
An observational study of Bone Marrow Failure and Trauma, run by University Hospital, Lille.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Failure, Trauma
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with spinal cord injury dating back less than 48 hours
- Men or women over 18 years of age
- Patients benefiting from social protection
- Surgery performed within 48 hours of the trauma
- Informed and signed consent by the patient or trusted person
Who cannot join
- Contra-indication to ensure surgical decompression within the first 48 hours following the trauma
- Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery)
- Severe cranial trauma associated
- History of autoimmune pathology
- Immunosuppressive therapy or long-term corticosteroid therapy
- Patients unable to comply with protocol requirements
Show all 10Show fewer
- Person benefiting from legal protection (guardianship / curator)
- Person deprived of liberty
- Patient unable to express consent
- Pregnant women
About this study
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.
- Conditions
- Bone Marrow Failure, Trauma
- Keywords
- Trauma, spinal cord, autoimmunity, antibody
- Medical subject headings
- Bone Marrow Failure Disorders, Wounds and Injuries, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anti glial fibrillary acid protein antibodies
Anti glial fibrillary acid protein antibodies measured into the cerebrospinal fluid
Measured: 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 (2)
Blood level of anti glial fibrillary acid protein antibodies
Anti glial fibrillary acid protein antibodies measured into the blood
Measured: 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
Measured using the American Society Injury Association score
Measured: in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study startSep 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Why it stopped: sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahed Zairi, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249129
- Sponsor's protocol ID
- 2016_42
- Other IDs
- 2017-A00661-52
- Acronym
- TRAME
- Status last verified
- Dec 2019
- First submitted
- 7 Aug 2017
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma
- ClinicalTrials.gov ID
- NCT03249129
- Acronym / sponsor ID
- TRAME / 2016_42
- Conditions
- Bone Marrow Failure, Trauma
- Keywords
- Trauma, spinal cord, autoimmunity, antibody
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Patients with spinal cord injury dating back less than 48 hours
- Men or women over 18 years of age
- Patients benefiting from social protection
- Surgery performed within 48 hours of the trauma
- Informed and signed consent by the patient or trusted person
Key exclusion criteria (10 listed)
- Contra-indication to ensure surgical decompression within the first 48 hours following the trauma
- Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery)
- Severe cranial trauma associated
- History of autoimmune pathology
- Immunosuppressive therapy or long-term corticosteroid therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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.
Severity of Neurological Impairment
Time frame: in the initial phase, at day 7, at 1 months, 3 months, 6 months and 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fahed Zairi, MD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Failure and Trauma, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.