Purpose The aim of this planned study is to evaluate the ability of a cranial microwave
scanner in conjunction with nine brain biomarkers (A beta 40, A beta 42, GFAP, H-FABP,
S100B, NF-L, NSE, UCH-L1 and IL-10) to detect and rule out traumatic intracranial
hemorrhage in an emergency department setting. Traumatic brain injury is a world-wide
topic of interest for researchers and clinicians. It affects 2% of the population
per annum and presents challenges for physicians as patients' initial signs and symptoms
do not always correlate with the extent of brain injury. The gold standard for diagnosis
of intracranial hemorrhage is head computerized tomography (CT) with the drawbacks
of high cost and radiation exposure. A fast, secure way of diagnosing without these
drawbacks has potential to make care more effective and reduce cost. Methods Study
will be prospective and enroll adult, consenting patients with head trauma who seek
emergency department care. Only patients where the treating physician prescribes a
head-CT will be included. The microwave scan and blood sampling will be performed
in close temporal proximity to the CT scan. Results will be analyzed with sensitivity,
specificity and receiver operator characteristics analysis to provide the best combination
of a number of biomarkers and the microwave scan. Conclusion This study will explore
the diagnostic accuracy of a head microwave scanner in combination with biomarkers
in ruling out intracranial hemorrhage in traumatic brain injury patients presenting
to the emergency department. Potentially, this combined diagnostic approach could
achieve both high sensitivity and high specificity, thereby reducing the need of CT-head
scans when managing these patients. Clinicaltrials.gov identifier: NCT04666766. Registered
December 11, 2020.
