BRAINI2

Biomarkers to improve diagnosis and management of mild traumatic brain injury in vulnerable patients

The challenge

Each year, an estimated 69 million people worldwide sustain a traumatic brain injury (TBI).[1] The majority of cases (80%) are mild TBI (mTBI), which is one of the most frequent causes of admission to the emergency department.[1] TBI disproportionately affects children, teenagers, and senior citizens.[2]

In the ED, doctors use cranial computed tomography (CCT) scan to assess whether mTBI patients have any intracranial lesions or complications.[3] CCTs pick up intracranial lesions in less than 10% of mTBI patients and less than 1% require neurosurgical intervention.[4] That said, it is crucial intracranial injuries are rapidly diagnosed so the patient’s condition can be managed.

Because it is hard to predict which patients may have intracranial lesions after mTBI, doctors overuse CCTs for patients with mTBI. This is problematic as CCTs expose patients to ionising radiation, associated with an increased risk of cancer.

Considering the high prevalence of mTBI, overuse of CCTs for mTBI patients causes overuse of ED resources, avoidable deleterious uncomfortable waiting times in the EDs, high costs and an increased risk of radiation exposure.[5][6]

Doctors need objective tools to identify which patients are at risk of intracranial lesions in order to better target CCT indications while minimising the risk of delayed diagnosis. Hospitals and healthcare systems need to optimise patients’ triage while limiting overuse of CCTs. There is also a need to alleviate ED overcrowding and improve mTBI management costs.

The solution

To make it easier to triage mTBI patients and reduce the overuse of CCTs, the solution supported by BRAINI2 is an automated diagnostic test, the VIDAS® TBI. This measures the levels of two biomarkers in blood within 12 hrs after a TBI.[6] A negative test result after mTBI could rule out an acute intracranial lesion, helping avoid unnecessary CCTs and observation periods.

The VIDAS® TBI is a simple solution to triage mTBI patients in the ED, limiting the prescription of CCT and length of stay for patients with a negative result. The test will improve ED resource use, reduce costs and lessen the need for radiologists. It will also decrease CCT-induced cancer costs and the associated burden on healthcare systems.

EIT Health has already supported the development and use of the test for the general adult population through a previous project, BRAINI.[7] BRAINI2 will further develop the solution, so it can be used for children and elderly patients, including those with existing neurological conditions. The team plans to develop a personalised approach for these vulnerable populations to support clinical decision-making.

Expected impact

This project promises to optimise and extend the clinical use of an innovative diagnostic test, the VIDAS® TBI, to vulnerable patients with mTBI: the elderly, including those with an underlying neurological condition, and children. It will lay the groundwork for age-appropriate guidelines for acute mTBI care and diagnostic decisions.

Ultimately, BRAINI2 promises to enhance the effectiveness of care for patients of all ages with mTBIs and limit unnecessary CCTs. In doing so, it will help to reduce radiation exposure and cancer risk, particularly in young children. This will reduce the burden of CCT-related cancer on healthcare systems. It will also decrease the length of ED stays, allowing hospitals to focus resources on patients more likely to benefit from ED care.

External Partners

• CHU Clermont-Ferrand
• Luzerner Kantonsspital (LUKS)

References

[1] Dewan, M. C., et al. (2018). Estimating the global incidence of traumatic brain injury. Journal of Neurosurgery, 130, 1-18.

[2] Levin, H. S. and Diaz- Arrastia, R. R. (2015). Diagnosis, prognosis, and clinical management of mild traumatic brain injury. Lancet Neurology, 14(5), 506-17.

[3] Haydel, M. J., et al. (2000). Indications for computed tomography in patients with minor head injury. The New England Journal of Medicine, 343, 100–5.

[4] Stiell, I. G., et al. (2005) Comparison of the Canadian CT head rule and the New Orleans Criteria in patients with minor head injury. JAMA, 294(12), 1511-8.

[5] Sheppard, J. P., et al. (2018. Risk of Brain Tumor Induction from Pediatric Head CT Procedures: A Systematic Literature Review. Brain Tumor Research and Treatment. [online] Available at: <https://escholarship.org/content/qt5gv9b1cc/qt5gv9b1cc.pdf?t=qfk1la> [Accessed 25 March 2022].

[6] Bazarian, J. J., et al. (2018). Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurology, 17(9), 782-789.

[7] Richard, M., et al. (2021). Study protocol for investigating the performance of an automated blood test measuring GFAP and UCH- L1 in a prospective observational cohort of patients with mild traumatic brain injury: European BRAINI study. BMJ Open. [online] Available at: <https://bmjopen.bmj.com/content/11/2/e043635> [Accessed 25 March 2022].