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The diagnosis of acute brain injury in the acute care setting is based on neurological examination and neuroimaging tools such as computed tomography scanning and magnetic resonance imaging. Clinicians have not been afforded the opportunity to use blood-based biomarkers for these conditions acutely. There are numerous blood-based biomarkers being used in medicine today, but no blood-based biomarker has been approved by the FDA for clinical use, nor has one been validated as a surrogate measure for clinical trials. Although there is an abundance of papers being published, many lack the rigorous methods and reporting required to adequately evaluate these markers for clinical use or as surrogate endpoints. Given all of this research, there is now an important need to validate these biomarkers. This chapter will review some of the most widely studied protein biomarkers for acute brain injury in the clinical setting, with an emphasis on traumatic brain injury and stroke. Also highlighted will be the gaps in the current state of knowledge and the role for blood-based biomarkers in future clinical trials.

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