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BRAINapt

BRAINapt is an international multicenter adaptive platform trial in TBI designed to improve bedside practices and outcomes in critically ill patients with TBI. It studies different interventions within three specific families of domains: (i) drugs, (ii) devices, (iii) non-drug neither device related. The platform enrolls critically ill adult patients with TBI. The primary outcome is the Glasgow Outcome Scale extended (GOSe), an ordinal outcome on eight points from death (1) to full recovery (8). Secondary outcomes will quality of life, cognition, mortality, organ support free days, ICU-free days, ventilator-free days, delirium. The trial uses a Bayesian adaptive framework to reach conclusions regarding superiority or futility based on posterior probability according to predetermined thresholds.

Contact: BRAINapt@crchudequebec.ulaval.ca

 

TRACK-TBI + CENTER-TBI

An International Collaboration to Improve the Precision of the Glasgow Outcome Scale Extended (GOSE) is a U.S. Department of Defense-funded project (2024–2027) that is using item response theory (IRT) and other modeling approaches to investigate strategies to measure functional limitations more precisely after TBI. The project is using data from the TRACK-TBI and CENTER-TBI studies and reflects a collaboration among investigators within these U.S. and European research networks. Principal investigator: Lindsay Nelson; Co-Investigators: Lindsay Wilson, Brooke Magnus, and Nancy Temkin; Other collaborators: Steve Balsis, Andrew Maas, Geoff Manley, David Menon, Ewout Steyerberg, and Sonia Jain.

TBI-REPORTER

TBI repeortal

The UK-TBI REpository and data PORTal Enabling discoveRy (TBI-REPORTER) is a new research platform for clinical TBI research in the UK. This exciting MRC/NIHR/MoD/ARUK funded initiative will bring together all the available research on TBI and make it accessible to scientists. By doing so, we hope to aid the development of new diagnostic techniques, therapeutic interventions, and personalized treatments for TBI. TBI-REPORTER will cover all age groups, including children and older adults, as well as particular groups like military personnel, athletes, prisoners, homeless individuals, and victims of domestic violence. The platform has four main pillars: a Data Hub; a Biomarker Repository; Experimental Medicine Network; and a Public and Patient Involvement and Engagement Initiative.

The data and samples in TBI-REPORTER will be available to researchers from the UK and around the world, through collaboration with individual studies affiliated to the project. This will speed up TBI research and improve our understanding of its lifelong impact on health, leading to better treatment and individualized care.

Website: https://tbi-reporter.uk/

Enquiries: tbi-reporter@medschl.cam.ac.uk

TBI MIssion

Traumatic brain injury is a major cause of disability and death in Australia. The Traumatic Brain Injury Mission is investing $50 million to improve patient recovery after brain injury. It will support projects that predict recovery outcomes, and/or identify the most effective care and treatments. The Mission for Traumatic Brain Injury is funded by the Australian Medical Research Future Fund (MRFF). Further information and funded projects are described at this link https://www.health.gov.au/our-work/mrff-traumatic-brain-injury-mission#:~:text=The%20Traumatic%20Brain%20Injury%20Mission,most%20effective%20care%20and%20treatments.

APAC

The APAC Cohort analysis is a study of whether lesion progression and clinical outcome are different in patients on antiplatelet agents and anticoagulants (the APAC cohort) when compared to patients not on these agents. 

  • The main analysis of the impact on clinical outcome is being driven by Harvey Levin and Claudia Robertson in TRACK-TBI and Marc Maegele in CENTER-TBI, with Hester Lingsma and Nancy Temkin providing methodological input. There have also been useful online discussions between Nancy Temkin and Ewout Steyerberg about analysis strategies, and Lindsay Wilson (from CENTER-TBI) will be liaising with outcome leads in TRACK –TBI to discuss harmonisation of outcome data.  This last issue will also inform the broader issue of cross calibrating/harmonising outcome assessments between the two studies.
  • The imaging study is being driven from Work Package 8 of CENTER-TBI (Cambridge), with Pratik Mukherjee facilitating a subsequent analysis in TRACK-TBI.  The CENTER-TBI imaging cohorts have been identified and propensity matching for control populations is now complete.
GAIN

Traumatic brain injury (TBI) is a leading cause of mortality, and the leading cause of neurodisability, globally. Less than 50% of the substantial inter-individual variability in outcome in TBI is explained by classical covariates. We know that genetic variation modulates TBI outcome, but past studies have been small with limited gene targets. The Genetic Associations in Neurotrauma (GAIN) Consortium will draw on large studies funded as part of the International Traumatic Brain Injury Research (InTBIR) initiative, supplemented with cohorts from past high-quality studies, to generate a well-characterized sample of patients with blood banked for genetic analysis. Our initial sample consists of over 7000 patients from the CENTER-TBI and TRACK-TBI studies, supplemented by historical datasets and past trials, but the potential exists to expand this to over 10,000 patients.  We will use this substantial resource to conduct the first ever genome-wide association study (GWAS) in TBI, aiming to identify biological mechanisms that modulate response and recovery from injury.  GAIN will also draw on the expertise of genetics consortia in other diseases, to integrate rigorous phenotype harmonization with state-of-the-art genotyping and analysis. Our outputs could transform our understanding of TBI biology, and provide future research dividends. Discovering these variants could characterise novel disease mechanisms, improve prognostic precision, identify new therapeutic targets, and allow patient stratification for precision medicine approaches. GAIN will also remain open to new partners, and foster the collection of DNA as part of any planned or future high quality observational trial or interventional study, since an expanding collection of DNA samples and well characterised phenotype could bear substantial scientific and clinical dividends.

DAQCORD

Data Access Quality & Curation for Observational Research Designs (DAQCORD) is developing a practical self-assessment and reporting method for clinical research studies. The goal is to capture key information about data acquisition, quality control measures, and curation in a tool that is linked to the dataset so that potential research collaborators can determine if the data meets their needs and expectations. This effort originated in the Data Analytics and Management working group of the International Traumatic Brain Injury Research (InTBIR) initiative, however the DAQCORD reporting system is expected to be relevant to many brain diseases and disorders.