I63
Conditions
Interventions
Group 1: Observational arm (prehospital biomarker POCT on an MSU) for dispatch-identified suspected stroke (symptom onset = 24 h).
Time points & procedures:
T0 (on scene, after routine IV placement):
single blood draw without an additional venipuncture.
T1 (immediately after draw): LVOCheck multiplex POCT (NT-proBNP, D-Dimer, H-FABP) on whole blood
read-out after ~10 min in the app with automatic storage.
T2 (after centrifugation of the same sample): second POCT run on heparin plasma to assess whole-blood vs. plasma equivalence
parallel aliquoting/biobanking of plasma for potential ancillary analyses.
T3 (in hospital): capture of the reference standard (final diagnosis incl. imaging) and usability/workflow feedback from HCPs
documentation in the eCRF.
No randomization
no treatment changes driven by the study. Study procedures run in parallel to standard care. (See protocol for details.
Sponsors
Charite - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Suspected stroke based on the initial dispatch center telephone triage • Symptom onset or last known well = 24 hours • Intravenous access established as part of standard care • Prehospital blood sampling feasible prior to treatment initiation • Written informed consent from the patient or legal representative (deferred consent if needed)
Exclusion criteria
Exclusion criteria: • Refusal to participate or withdrawal of written consent (by patient or legal representative) • Blood sampling not possible for any reason • Unable to perform a full NIHSS due to clinical status (e.g., coma/intubated) • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of LVOCheck to predict large-vessel occlusion (reference standard: final in-hospital diagnosis), expressed as sensitivity and specificity based on integrated biomarker (NT-proBNP, D-Dimer, H-FABP) and clinical data. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Matrix equivalence: agreement of POCT measurements in whole blood vs. plasma for NT-proBNP, D-Dimer and H-FABP. • Clinical utility: physician-reported impact of biomarker values and overall risk score on prehospital triage/transport decisions. • Workflow integration/usability: feasibility and user feedback (human factors) regarding routine MSU implementation. • Safety/performance: frequency and severity of technical malfunctions plus proportions of false-positive and false-negative LVO classifications. | — |
Countries
Germany
Contacts
Public ContactJoachim Weber
Charite - Universitätsmedizin Berlin
Outcome results
None listed