AUTHOR=Geisler Frederik , Haacke Lisa , Lorenz Maren , Schwabauer Eugen , Wendt Matthias , Bernhardt Lydia , Dashti Eman , Freitag Erik , Kunz Alexander , Hofmann-Shen Christina , Zuber Martina , Waldschmidt Carolin , Kandil Farid I. , Kappert Kai , Dang-Heine Chantip , Lorenz-Meyer Irina , Audebert Heinrich J. , Weber Joachim E. 

TITLE=Prospective collection of blood plasma samples to identify potential biomarkers for the prehospital stroke diagnosis (ProGrEss-Bio): study protocol for a multicenter prospective observational study

JOURNAL=Frontiers in Neurology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1201130

DOI=10.3389/fneur.2023.1201130

ISSN=1664-2295

ABSTRACT=Introduction
Intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are well-established evidence-based and time-critical therapies reducing morbidity and mortality in acute ischemic stroke (AIS) patients. Exclusion of intracerebral hemorrhage (ICH) is mandatory and is performed by cerebral imaging so far. Mobile stroke units (MSUs) have been shown to improve functional outcome by bringing cerebral imaging and IVT directly to the patient, but they have limited coverage. Blood biomarkers clearly distinguishing between AIS, ICH and stroke mimics (SM) could provide an alternative to cerebral imaging, if concentration changes are detectable in the hyperacute phase after stroke with high diagnostic accuracy. Here, we will take blood samples in a prehospital setting to evaluate potential biomarkers.
Methods and Analysis
We plan a prospective, observational study of 300 patients with suspected stroke and symptom onset ≤ 4.5 hours before collection of biomarkers. Recruitment of study participants will be performed at three sites in Berlin, Germany, during MSU deployments. Focus of the study is the collection of blood samples prehospital at scene and, in patients with AIS or ICH, at a second time point. All samples will be analyzed using targeted and untargeted analytical approaches. Study-related information of patients, including medical information and discharge diagnosis from the subsequent treating hospital, will be collected and documented in an electronic case report form (eCRF).
Discussion
This study will evaluate whether a single blood biomarker or a combination of biomarkers can distinguish patients with AIS and ICH as well as patients with stroke and SM in the early phase after symptom onset in the prehospital setting. In addition, kinetics of blood biomarkers in AIS and ICH patients will be investigated.  Our aim is to evaluate new ways to reliably diagnose stroke in the prehospital setting and thus accelerate the application of evidence-based therapies in stroke patients.
Ethics and Dissemination
This study was approved by the local ethics committee of the Charité (EA: EA4/082/18). Results of the study will be published in peer-reviewed journals.
Study registration
The study was registered on January 6, 2021 in the German Clinical Trials Register (“Deutsches Register klinischer Studien”) with the identifier DRKS00023063.