Developing and Validating Blood and Imaging BIOmarkers of AXonal Injury Following Traumatic Brain Injury
BIO-AX-TBI
2 other identifiers
observational
313
4 countries
5
Brief Summary
Observational longitudinal study assessing outcomes following moderate-severe traumatic brain injury (TBI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2017
CompletedFirst Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMarch 31, 2022
March 1, 2022
3.4 years
April 27, 2018
March 29, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Change in diffusion tensor imaging measures over time
Fractional anisotropy (FA)
10 days - 6 weeks, 6 months and 12 months
Brain atrophy rates
Brain tissue volume changes over time.
10 days - 6 weeks, 6 months and 12 months
Change in levels of fluid biomarkers in blood
Neurofilament light and Tau protein
0-5 days, 5-10 days, 10 days - 6 weeks, 6 months and 12 months
Change in levels of fluid biomarkers in cerebral fluid
Neurofilament light and Tau protein
48 hours to 7 days
Study Arms (4)
TBI - MRI / bloods / cognitive / clinical outcomes
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
TBI - Advanced MRI / bloods / cognitive / clinical 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.
TBI - microdialysis / adv. MRI / cognitive / clinical
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.
Healthy volunteer
Single assessment using MRI, bloods and cognitive testing.
Interventions
Magnetic Resonance Imaging
Sampling of serum
Monitoring of cerebral fluid protein levels
Battery of tests to assess cognitive function, patient outcomes
Advanced MRI
Eligibility Criteria
250 traumatic brain injury patients from ITU / major trauma ward.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Centre Hospitalier Universitaire Vaudoiscollaborator
- University College, Londoncollaborator
- Istituto Di Ricerche Farmacologiche Mario Negricollaborator
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinicocollaborator
Study Sites (5)
Fondazione IRCCS, Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri"
Milan, Italy
University Medical Centre
Ljubljana, Slovenia
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Imperial College London
London, W12 0NN, United Kingdom
Related Publications (1)
Graham NSN, Zimmerman KA, Bertolini G, Magnoni S, Oddo M, Zetterberg H, Moro F, Novelli D, Heslegrave A, Chieregato A, Fainardi E, Fleming JM, Garbero E, Abed-Maillard S, Gradisek P, Bernini A, Sharp DJ. Multicentre longitudinal study of fluid and neuroimaging BIOmarkers of AXonal injury after traumatic brain injury: the BIO-AX-TBI study protocol. BMJ Open. 2020 Nov 10;10(11):e042093. doi: 10.1136/bmjopen-2020-042093.
PMID: 33172948BACKGROUND
Biospecimen
Blood and cerebral microdialysis samples collected during longitudinal study, where appropriate (as per protocol).
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Sharp
Imperial College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 23, 2018
Study Start
November 30, 2017
Primary Completion
April 30, 2021
Study Completion
December 30, 2021
Last Updated
March 31, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share