Affiliated Studies & Collaborations
Affiliated Studies & Collaborations
TBI-REPORTER Affiliation for new research studies: Advantages and opportunities
One of the key functions of TBI-REPORTER is to provide a platform for secondary use of data and samples from past studies based on FAIR (findable, accessible, interoperable, reusable) storage of data following completion of research projects, and the TBI-REPORTER Data Hub provides a mechanism to do this.
However, it is just as (and possibly more) important to ensure that all new studies in TBI also comply with these requirements, and funders routinely ask about arrangements for legacy storage and access of data. TBI-REPORTER offers a platform to address this need, with greater efficiency (the processes for banking and retrieval are well established), reduced costs (from economies of scale), and full data security (using ISO 27001 compliant platforms in the UK Secure eResearch Platform). The costs such legacy storage vary with size and complexity of individual studies (imaging and genetic data are typically require more storage than simple data), but, typically, the costs of such engagement is less than 1% of the budget of most “data-only” projects. Indeed, for small datasets with limited or no imaging we may waive costs.
Except for TRANSFORM-TBI (where TBI-REPORTER provides technical and infrastructure collaboration and a discoverable digital platform; see later) all new studies affiliated with TBI reporter have:
- Access to well developed and tested modular protocols, modular text to cover aspects of research for ethical committee submission, REDCap-based clinical report forms. These modular resources have been designed to allow modification and refinement for individual studies
- Access to the patient and public involvement and engagement panels, and clear guidelines on how these need to resourced and funded.
- Access to proven procedures and pipelines for biosample collection, processing, transfer, banking and retrieval (using the Cambridge MRC Epidemiology Biorepository)
- Encouragement to ensure that residual samples obtained for individual studies are discoverable and available for reuse in future analyses
- Separate storage of a single EDTA sample (for DNA extraction and genetic studies) and aliquot of serum (for legacy biomarker analysis). In particular, the collation of phenotype, outcome, and DNA would allow appropriately powered genetic association studies, which would be impossible in the context of any individual studies
- Access to our core laboratory facilities for biomarker analysis in the Biomarker Factory at University College London, including access to shared control and calibration data
- An expectation of upload of datasets after study completion which allows secure storage of study data for legacy access. This includes clinical data, outcomes, imaging (in BIDS format), biomarker results, and genetic data (typically as VCF files)
- Harmonisation/standardisation of these data so that combined analysis with other studies is facilitated
- Discoverability on the TBI-REPORTER platform to facilitate studies being used for secondary or combined analysis
Funded studies
Toci-TBI
Full name: Modulating interleukin-6 pathways to understand the effect of systemic inflammation on detrimental neuroinflammation following Traumatic Brain Injury
PI: Dr Edward Needham
Study start and end dates: Oct 2024 -> Oct 2029
Funder: MRC (Experimental Medicine stream)
Summary: Systemic inflammation is ubiquitous in TBI and is thought to independently drive harmful neuroinflammation. Numerous studies have implicated high blood interleukin-6 concentration as a predictor of poor outcome following TBI. In this clinical trial, we will treat patients with the interleukin-6 receptor blocker tocilizumab within 2 days of injury to explore whether by blocking systemic interleukin-6 we can reduce harmful brain inflammation.
IMPROVE-CSDH and nCSDH
Full name: Specialist surgical care systems and their relevance to patient outcome and experience: learning from an improvement study in the care of chronic subdural haematoma (IMPROVE-CSDH): and the National Chronic Subdural Data Hub (nCSDH)
PI: Dr Daniel Stubbs
Study start and end dates: December 2024 – December 2029
Funder: NIHR (Advanced Fellowship)
Summary: chronic subdural haematoma (cSDH) is a common consequence of traumatic injury in older patients who are frail with complex medical needs. Operative (and non-operatiive) care is split between institutions and accurate data challenging to obtain due to inaccuracies in diagnostic and procedural codes. IMPROVE-CSDH is a programme evaluation of new care pathways for cSDH that have been designed to span institutions it will understand barriers and facilitators to implementation as well as conduction quasi-experimental assessment of impact and health economic analyses. Its impact is increased by the feasibility assessment of a national data resource for cSDH in eight neurosurgical centres, capturing data to understand the links between geography, referral route, and outcome while developing an infrastructure for national audit and future trials.
BRaINS-TBI
Full name: Biomarkers for RAtional Investigation for Neurological decision Support in TBI: BRaINS-TBI
PI: Dr Virginia Newcombe
Study start and end dates: January 2025 to December 2028
Funder: NIHR EME (Award ID: NIHR159241)
Summary: BRAINS-TBI is a cohort study of 2048 patients with embedded RCT of ~800 patients who present to 10 UK Emergency Departments after sustaining a mild traumatic brain injury. It aims to answer two key questions: 1) Can blood biomarkers reduce the number of CT scans performed in the ED for mild TBI? 2) Can Biomarkers identify patients at higher risk of long-term problems following mild TBI? Health economic and Communication of Risk work packages are planned. Findings in adults will be tested in a paediatric cohort being recruited separately at Alder Hey Hospital, Liverpool.
Further funded studies
TBI-TS
Full name: Trasumatic Brain Injury Thresholds Study
PI’s: Prof David Sharp
Study start and end dates: 01/09/2025 – 31/08/2027
Funders: MRC
Summary: Rugby is a collision sport associated with head acceleration events (HAEs) and increased risk of TBI. Furthermore, there is epidemiological and pathological evidence to suggest repeated head impact exposure from rugby increases the risk of neurodegenerative disease in the long term. The characteristics of HAEs that result in clinically significant acute and longer-term brain injury are poorly understood.
We will recruit around 500 elite rugby players (50% female) from rugby league and union to undergo blood sampling at multiple time points (pre- and post- game). We will collect blood-based biomarker data (capillary blood sampling and multiplexed assays of a wide range of proteins relevant to central nervous system disease) from a large sample of players experiencing a wide range of HAEs. This will be analysed in relation to kinematic data from instrumented mouthguards, including advanced computational models of brain strain, to better understand the neuroanatomical patterns of biomechanical strain on brain tissue.
Combining blood biomarkers, kinematic data and computational modelling we aim to define the biomechanical threshold for acute TBI in elite rugby to better inform important decisions regarding head acceleration event exposure and player welfare.
TRANSFORM-TBI
Full name: Transdisciplinary Research Accelerating Neuropatholgy Studies and Facilitating Open Research Methods in TBI.
PI’s: Dr Douglas Smith; Dr Edward Lee; Prof Willie Stewart
Study start and end dates: 2024 – 2029
Funders: NIH USA (National Institute of Neurological Diseases and Stroke, and National Institute of Aging).
Summary: TRANSFORM-TBI will investigate the link between traumatic brain injuries (TBI) and Alzheimer’s disease and related dementias (ADRD). Using an extensive tissue bank including over 1,000 samples, the researchers aim to uncover the underlying biological mechanisms of TBI-related neurodegeneration (TReND) from a variety of brain injury types. Researchers hope that by understanding TReND, they might gain further insight into how ADRD develops, and inform the development of better preventative measures and treatments.
TBI-REPORTER will provide TRANSFORM-TBI with technical and infrastructure collaboration, including input into establishing a digital pathology platform for the project.
SUNLIGHT
Full name: Study Using Neurovascular Longitudinal Insights to Guide Head Injury Treatment
PI: Dr Aravinthan Varatharaj
Study start and end dates: 11/2024 – 11/2027
Funders: Ferblanc and the RFU
Summary: Does blood-brain barrier permeability in the subacute stage after TBI predict downstream neurodegeneration in the chronic stage?
Full name: Point of care testing in emergency departments after mild traumatic brain injury
PI: Dr Virginia Newcombe
Study start and end dates: TBC
Funders: Abbott
Summary: A systems engineering approach will aim to assess the feasibility, potential benefits, and practical considerations of integrating biomarkers and adjunct clinical decision support tools (CDSTs) into mTBI management in UK NHS utilising health system engineering methods.
It seeks to understand clinician perspectives, ED workflow and process, data flow, decision making, and organisational infrastructure. Putative intervention points for biomarker and CDSTs will be proposed and explored with stakeholders, to delineate both the process and outcome metrics needed for effective and acceptable implementation.
Prehospital BRAINS-TBI
Full name: Prehospital sampling of brain injury biomarkers in mild traumatic brain injury: a feasibility study (add on study to BRaINS-TBI
PI’s: Dr Daniel Whitehouse and Dr Virginia Newcombe
Study start and end dates: 04/2025 – 12/2025
Funders: i4i FAST call
Summary: This study is meant to show feasibility of collecting biomarker samples in prehospital phase.