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Trial record 29 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Developing and Validating Blood and Imaging BIOmarkers of AXonal Injury Following Traumatic Brain Injury (BIO-AX-TBI)

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ClinicalTrials.gov Identifier: NCT03534154
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Collaborators:
Centre Hospitalier Universitaire Vaudois
University College, London
Istituto Di Ricerche Farmacologiche Mario Negri
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Traumatic brain injury (TBI) occurs when the brain is physically damaged, for example after a car crash. It is common and survivors often have major on-going problems. It is very difficult to predict how patients will do after TBI. One reason for this is that clinicians and researchers are unable to measure all the effects of TBI. An important factor is that the connections between nerve cells are damaged by the impact on the brain of an injury (axonal injury). This damage has been difficult to measure in the past, but new ways to scan the brain and more sensitive ways of picking up the effects of this injury in the blood could change this. In other parts of medicine tests of this type have had a dramatic effect on how clinicians treat patients. For example, the products of heart muscle damage that have leaked into the blood can be used identify a heart attack and guide treatment. Clinicians need similar tests to be available in TBI. This should be possible as the products of axonal injury also leak into the blood and researchers have a sensitive way to pick this up. An accurate test for axonal injury would guide treatment choices and allow clinicians to predict how patients will recover. The investigators have brought together an international team who have been working on different aspects of this problem for many years. Together the investigators will conduct a large study to identify the best measures of axonal injury. The investigators will carefully test whether these measures help predict outcomes and will study where the blood markers come from using a safe method to measure the effects of axonal injury directly from the brain. The work links into some large projects that have already started and will use a standard way to assess patients after their injury. This is important because it will allow researchers to share results across studies. The investigators hope the work will allow us to identify a blood marker for TBI that could be widely used to quickly identify the presence of axonal injury. The investigators will also show what brain imaging measure is best at picking up axonal injury and how best to combine the measures to best predict how patients recover. This will allow doctors to diagnose problems after TBI more accurately, choose the right treatments and give patients and their families accurate advice about what will happen after discharge from hospital.

Condition or disease Intervention/treatment
Traumatic Brain Injury Diagnostic Test: MRI Diagnostic Test: Blood Sampling Diagnostic Test: Microdialysis Diagnostic Test: Neuropsychological tests

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing and Validating Blood and Imaging BIOmarkers of AXonal Injury Following Traumatic Brain Injury
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Work Package 1
In a large multi-centre cohort of adult moderate/severe TBI patients we aim to identify the most informative plasma biomarker(s) of the severity of axonal injury. We will characterise their time course, focusing on neurofilament light (NFL) and tau, and relate these to magnetic resonance imaging (MRI) measures of axonal injury. Using logistic regression we will then test whether these measures contribute to the prediction of clinical outcome at twelve months
Diagnostic Test: MRI
Magnetic Resonance Imaging

Diagnostic Test: Blood Sampling
Sampling of serum

Diagnostic Test: Neuropsychological tests
Battery of tests to assess cognitive function, patient outcomes

Work Package 2
In a subgroup of the patients recruited to WP1 we will use advanced MRI and longitudinal assessments to provide a more detailed description of the relationship between the plasma biomarkers and outcome after TBI. We will test whether advanced diffusion and myelin integrity measures correlate with plasma biomarkers and whether early plasma biomarker levels predict neurodegeneration measured by progressive atrophy after TBI.
Diagnostic Test: MRI
Magnetic Resonance Imaging

Diagnostic Test: Blood Sampling
Sampling of serum

Diagnostic Test: Neuropsychological tests
Battery of tests to assess cognitive function, patient outcomes

Work Package 3
In a second subgroup of patients recruited to WP1 we will combine microdialysis, neuroimaging and plasma sampling of axonal proteins to provide a deeper understanding of the mechanisms of axonal injury progression and use this approach to investigate the axonal origin of the plasma biomarkers.
Diagnostic Test: MRI
Magnetic Resonance Imaging

Diagnostic Test: Blood Sampling
Sampling of serum

Diagnostic Test: Microdialysis
Monitoring of cerebral fluid protein levels

Diagnostic Test: Neuropsychological tests
Battery of tests to assess cognitive function, patient outcomes




Primary Outcome Measures :
  1. Change in diffusion tensor imaging measures over time [ Time Frame: 10 days - 6 weeks, 6 months and 12 months ]
    Fractional anisotropy (FA)

  2. Brain atrophy rates [ Time Frame: 10 days - 6 weeks, 6 months and 12 months ]
    Brain tissue volume changes over time.

  3. Change in levels of fluid biomarkers in blood [ Time Frame: 0-5 days, 5-10 days, 10 days - 6 weeks, 6 months and 12 months ]
    Neurofilament light and Tau protein

  4. Change in levels of fluid biomarkers in cerebral fluid [ Time Frame: 48 hours to 7 days ]
    Neurofilament light and Tau protein



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
250 traumatic brain injury patients from ITU.
Criteria

Inclusion Criteria:

  • A diagnosis of moderate/severe traumatic brain injury (TBI) as classified using the Mayo classification system;
  • Healthy controls will be age-matched to our TBI patients and will not have a history of significant neurological or psychiatric conditions.

Exclusion Criteria:

  • Unwillingness or inability to follow the procedures required
  • Bilateral fixed dilated pupils
  • For MRI, contra-indication to MRI scanning, assessed by a standard pre-MRI questionnaire (e.g. presence of ferromagnetic implants in the body, claustrophobia, pregnancy) if considered for the imaging strand of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534154


Contacts
Contact: Karl A Zimmerman kaz11@ic.ac.uk
Contact: Joanne Fleming joanne.fleming@marionegri.it

Locations
Italy
Fondazione IRCCS, Ca' Granda Ospedale Maggiore Policlinico Recruiting
Milan, Italy
Contact: Federico Moro       federico.moro@marionegri.it   
IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri" Recruiting
Milan, Italy
Contact: Joanne Fleming       joanne.fleming@marionegri.it   
Slovenia
University Medical Centre Recruiting
Ljubljana, Slovenia
Contact: Primoz Gradisek       primoz.gradisek@kclj.si   
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland
Contact: Samia A Maillard       samia.abed-maillard@chuv.ch   
United Kingdom
Imperial College London Recruiting
London, United Kingdom, W12 0NN
Contact: Karl Zimmerman       kaz11@ic.ac.uk   
Sponsors and Collaborators
Imperial College London
Centre Hospitalier Universitaire Vaudois
University College, London
Istituto Di Ricerche Farmacologiche Mario Negri
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
Principal Investigator: David Sharp Imperial College London

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03534154     History of Changes
Other Study ID Numbers: 230221
MR/R004528/1 ( Other Grant/Funding Number: ERA-NET )
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System