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Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies

Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04612218
Acronym
BIO-FAST
Enrollment
176
Registered
2020-11-02
Start date
2019-11-08
Completion date
2021-07-28
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Stroke, Ischemic Stroke, Stroke

Keywords

blood biomarkers, stroke diagnosis, stroke, biomarkers, reperfusion therapies, acute stroke therapy, prehospital stroke management

Brief summary

Stroke is the first cause of death among Spanish women and main cause of disability. Reperfusion therapies of the occluded artery remain the only useful approach in acute ischemic stroke. However, the efficacy of these strategies is highly time-dependent and due to the need of neuroimaging (CT or MRI) to differentiate between ischemic and hemorrhagic stroke, impossible to be performed at the pre-hospital level. The investigators aim to set-up a point of-care (POC) device to validate a biomarker panel differentiating ischemic and hemorrhagic stroke at the pre-hospital level using a blood sample and to validate a second biomarker panel for the early identification of patients with large vessel occlusions (LVO), which are candidates for mechanical thrombectomy. For that, the investigators will recruit a 300 patients' cohort with pre-hospital blood samples using available POCs for each of those markers.

Interventions

None listed

Sponsors

Hospitales Universitarios Virgen del Rocío
CollaboratorOTHER
Hospital Alta Resolución Sierra Norte
CollaboratorUNKNOWN
Hospital San Juan de Dios Aljarafe
CollaboratorUNKNOWN
Hospital Universitario Reina Sofia de Cordoba
CollaboratorOTHER_GOV
Hospital Universitario Virgen Macarena
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* I.1: Patients \> 18 years old. * I.2: Stroke code activated by the coordinator centre. * I.3: \< 6 hours from symptoms onset. In the case of stroke with uncertain chronology or wake-up stroke, the initial time will be considered as the last moment the patient was seen fine.

Exclusion criteria

* E.1: Prehospital diagnosis different of stroke. * E.2: Impossibility of getting a prehospital blood sample. * E.3: Refusal to provide the informed consent by the patient/relative.

Design outcomes

Primary

MeasureTime frameDescription
Stroke subtype diagnostic accuracythrough study completion, an average of 2 yearsStroke subtype diagnostic (% ischemic versus % hemorrhagic and % stroke mimics) will be determined by clinical and neuroimaging criteria at hospital arrival and compared with diagnostic accuracy of a blood biomarkers based test
Reperfusion ratesthrough study completion, an average of 2 years
Times to reperfusionthrough study completion, an average of 2 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026