Microwave scan and brain biomarkers to rule out intracranial hemorrhage : study protocol of a planned prospective study (MBI01)
(2022) In European Journal of Trauma and Emergency Surgery 48(2). p.1335-1342- Abstract
Purpose: The aim of this planned study is to evaluate the ability of a cranial microwave scanner in conjunction with nine brain biomarkers (Aβ40, Aβ42, 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... (More)
Purpose: The aim of this planned study is to evaluate the ability of a cranial microwave scanner in conjunction with nine brain biomarkers (Aβ40, Aβ42, 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.
(Less)
- author
- Vedin, Tomas LU ; Bergenfeldt, Henrik LU ; Holmström, Emanuel LU ; Lundager-Forberg, Jakob LU and Edelhamre, Marcus LU
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Biomarkers, Brain hemorrhage, traumatic, CT scan, X-ray, Microwaves, TBI traumatic brain injury
- in
- European Journal of Trauma and Emergency Surgery
- volume
- 48
- issue
- 2
- pages
- 1335 - 1342
- publisher
- Urban & Vogel
- external identifiers
-
- pmid:33944977
- scopus:85105908188
- ISSN
- 1863-9933
- DOI
- 10.1007/s00068-021-01671-7
- language
- English
- LU publication?
- yes
- additional info
- Funding Information: Open access funding provided by Lund University. Study will be partly funded by the Gorthon Foundation, Helsingborg, Sweden.
- id
- 9d8e43b5-16a9-4cda-ae01-ea810aab2d6e
- date added to LUP
- 2021-06-09 14:57:42
- date last changed
- 2024-04-06 04:52:24
@article{9d8e43b5-16a9-4cda-ae01-ea810aab2d6e,
abstract = {{<p>Purpose: The aim of this planned study is to evaluate the ability of a cranial microwave scanner in conjunction with nine brain biomarkers (Aβ40, Aβ42, 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.</p>}},
author = {{Vedin, Tomas and Bergenfeldt, Henrik and Holmström, Emanuel and Lundager-Forberg, Jakob and Edelhamre, Marcus}},
issn = {{1863-9933}},
keywords = {{Biomarkers; Brain hemorrhage, traumatic; CT scan, X-ray; Microwaves; TBI traumatic brain injury}},
language = {{eng}},
number = {{2}},
pages = {{1335--1342}},
publisher = {{Urban & Vogel}},
series = {{European Journal of Trauma and Emergency Surgery}},
title = {{Microwave scan and brain biomarkers to rule out intracranial hemorrhage : study protocol of a planned prospective study (MBI01)}},
url = {{http://dx.doi.org/10.1007/s00068-021-01671-7}},
doi = {{10.1007/s00068-021-01671-7}},
volume = {{48}},
year = {{2022}},
}