Severe Traumatic Brain InjuryICON-TBINCT03659006
Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
A study testing Biological Collection in people with Severe Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Biological Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2018to 30 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- patient ≥ 18 years old at the time of inclusion
- Written and informed consent obtained from the family / proxy
- Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission
- Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization
- Absence of contraindications to perform an MRI
- Patient affiliated to a social security scheme (free State medical aid excluded)
Who cannot join
- Patient under protection of the law (guardianship or tutorship)
- TBI of ballistic origin
- Pregnant woman
- Pre-existing cerebral disease that can bias the MRI scan evaluation
- Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)
- Patient with severe impairment of vital and / or life-threatening function with disability prior TBI
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- Neurological antecedent susceptible to interfere with clinical evolution at one year
- Severe cardiogenic shock
- Severe respiratory impairment
- Extra-brain injuries involving immediate life-threatening
- Hemoglobin level below 9g / dL
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Anesthesy department - Hôpital Pitié Salpêtrière
Paris, 75013
DEGOS Vincent, MD, 0142163761, vincent.degos@aphp.fr
About this study
Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.
The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.
Read more
The secondary objectives are:
- To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,
- To explore the contribution of the adaptive immune response in the persistent activation of the immune response,
- To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,
- To establish a correlation between the pathology and the physio-pathology of TBI.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Biological Collection
- Keywords
- inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological CollectionBiological
Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year
| Study group | Role | What they receive |
|---|---|---|
| Biological Collection | Experimental | Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year Receives: Biological: Biological Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.
Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365
Measured: Day 42 and 12 months
Secondary outcomes (1)
Concentrations of biomarkers such as Tau protein and beta-amyloid plaques in serum and cerebrospinal fluid (Aβ1-42, T-tau, and P-tau181P and Interleukin 1)
Plasma and Serum biological collection, multimodal MRI database, clinical database
Measured: Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start15 Oct 2018
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, University of Cambridge, Mario Negri Institute for Pharmacological Research
- Responsible party
- Sponsor
- Investigators
- Vincent Degos, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659006
- Sponsor's protocol ID
- K171201J
- Acronym
- ICON-TBI
- Status last verified
- Jul 2018
- First submitted
- 9 Jul 2018
- Last updated
- 23 Oct 2018
- 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Neuroinflammatory Biomarkers of Neuro-radiological Evolution in Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03659006
- Acronym / sponsor ID
- ICON-TBI / K171201J
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- inflammatory Biomarkers, Traumatic brain injury, multimodal MRI, tertiary lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hopital Universitaire Robert-Debre, University of Cambridge, Mario Negri Institute for Pharmacological Research
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 6 Sep 2018 (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.
Tertiary lesions responsible of the neurological decline after severe traumatic brain injury (TBI) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal MRI imaging and biological biomarkers during the acute phase after traumatic brain injury.
The main objective is to identify if the level of IL-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative MRI performed in post-resuscitation and at one year (quantitative ΔIRM) in traumatic brain injuried patients.
The secondary objectives are:
- To understand the links between the acute and chronic neuro-inflammatory phase in a population of TBI,
- To explore the contribution of the adaptive immune response in the persistent activation of the immune response,
- To Examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging,
- To establish a correlation between the pathology and the physio-pathology of TBI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological Collection | Experimental | Biological: Biological CollectionBlood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient ≥ 18 years old at the time of inclusion
- Written and informed consent obtained from the family / proxy
- Patient hospitalized in neuro-ICU following severe TBI with GCS ≤ 8 at admission
- Intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization
- Absence of contraindications to perform an MRI
Key exclusion criteria (11 listed)
- Patient under protection of the law (guardianship or tutorship)
- TBI of ballistic origin
- Pregnant woman
- Pre-existing cerebral disease that can bias the MRI scan evaluation
- Contraindications to the MRI (pace maker, medical device incompatible with MRI, metal plates, ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological CollectionBlood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year | Biological | Biological Collection |
Primary outcome
Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI.
Time frame: Day 42 and 12 months
Brain volume evolution assessed by quantitative MRI between Day 42 and Day 365
1 secondary outcome
Concentrations of biomarkers such as Tau protein and beta-amyloid plaques in serum and cerebrospinal fluid (Aβ1-42, T-tau, and P-tau181P and Interleukin 1)
Time frame: Blood and CSF samples collected at Day1, Day2, Day3, Day5 and Day7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- 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.
Vincent Degos, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Collection in people with Severe Traumatic Brain Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent Degos, PU-PH (01 42 16 37 61, vincent.degos@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-1 level in blood predict changes in brain volume assessed by quantitative MRI. (time frame: Day 42 and 12 months). 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 23 Oct 2018.