Clinical trial NCT04612218: Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies
Official title: Biomarkers for Initiating Onsite and Faster Ambulance Stroke Therapies (BIO-FAST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Ischemic Stroke
Hemorrhagic Stroke
Keywords: blood biomarkers
stroke diagnosis
stroke
biomarkers
reperfusion therapies
acute stroke therapy
prehospital stroke management
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
Collaborators: name: Hospitales Universitarios Virgen del Rocío
name: Hospital Alta Resolución Sierra Norte
name: Hospital San Juan de Dios Aljarafe
name: Hospital Universitario Reina Sofia de Cordoba
First posted: 2020-11-02
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, in whom health care services activate a stroke code, and the patient is transferred to the reference centre, within 6 hours from symptoms onset.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stroke subtype diagnostic accuracy
timeFrame: through study completion, an average of 2 years
measure: Reperfusion rates
timeFrame: through study completion, an average of 2 years
measure: Times to reperfusion
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital de Alta Resolución Sierra Norte
city: Sevilla
country: Spain
facility: Hospital San Juan de Dios Aljarafe
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Joan Montaner, PhD
role: STUDY_CHAIR
References: