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"Prospective collection of blood plasma samples for the detection of suitable biomarkers for prehospital stroke detection"
Tral document in the German Clinical Trials Register
"ProGrEss Bio" aims to develop a biomarker panel that can be used to diagnose strokes in the ambulance, distinguish between different subtypes and differentiate them from other diseases. Patients with a suspected stroke who are being treated by an emergency doctor in one of the three Berlin "STEMOs" are included. When taking blood samples during emergency treatment, the neurological emergency physicians take some additional blood from the patients. Provided the patient gives consent, the sample is analysed in a so-called "multi-omics" approach for possibly altered proteins (proteomics), genes (genomics), RNA (transcriptomics) and metabolites (metabolomics).
Since the blood samples are taken before the patient is admitted to hospital and thus at a very early stage of the disease, there is a chance to detect early changes in the concentration of possible biomarkers. By taking a second blood sample after at least 30 minutes, the kinetics can also be examined.
Initially, 300 patients are to be included in the current "discovery" phase.
Up to now, the diagnosis of a stroke in an ambulance has only been possible with expensive special equipment ("STEMO"). Early knowledge of whether a patient is suffering from an ischaemic or a cerebral stroke can be decisive. Alternative possibilities of prehospital stroke diagnosis (see "ULTRAFAST") ideally allow earlier treatment and thus a lower risk of permanent impairment ("B_PROUD" study). A therapy by means of thrombolysis (dissolving a blood clot with medication), for example, could be administered directly in the ambulance – under telemedical monitoring – as in "STEMO". If a thrombectomy (mechanical reopening of a vessel occlusion) is necessary, patients could be taken directly to a specialised clinic where the intervention can already be prepared.
Charité study team
- Dr. Joachim Weber, Head of the Study, Medical Head of "STEMO 3600" (Fire Station Charlottenburg-Nord)
- Prof. Dr. Heinrich Audebert, Deputy Study Director
- Prof. Dr. med. Kai Kappert, Institute for Laboratory Medicine, Clinical Chemistry and Pathobiochemistry, Deputy Study Director
- Dr. rer. nat. Farid Kandil, Biometrician/Statistical Advisor
- Dr. Frederik Geisler, Study Physician
- Irina Lorenz-Meyer, Study Coordinator
Recruiting Physicians at "STEMO 3600"
- Dr. Eman Dashti
- Erik Freitag
- Marc Schehadat
- Dr. Martina Zuber
Physicians at "STEMOs 4390" and "STEMO 6100"
- Eugen Schwabauer, Medical Head of "STEMO 4390", Vivantes Klinikum Neukölln (Fire Station Mariendorf)
- Dr. Matthias Wendt, Medical Head of "STEMO 6100", Unfallkrankenhaus Berlin
Further cooperation partners
- Prof. Dr. Norbert Hübner, Max Delbrück Center for Molecular Medicine Berlin-Buch
- Dr. Jennifer Kirwan, Max Delbrück Center for Molecular Medicine Berlin-Buch
- Dr. Philipp Mertins, Max Delbrück Center for Molecular Medicine Berlin-Buch
- Prof. Dr. Tobias Pischon, Max Delbrück Center for Molecular Medicine Berlin-Buch
STEMO – Stroke Emergency Mobile
The Stroke Emergency Mobile (STEMO), a specialized ambulance vehicle, equipped with a computed tomography (CT) scanner, point of care laboratory devices and staffed with a trained team of specialists in acute stroke care (one neurologist, one paramedic and one radiology assistant) is available for prehospital thrombolysis of patients with acute ischemic stroke in Berlin, Germany.
More information/project description