Clinical trial NCT05833945: Potential Use of a POCT for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
Official title: Study of the Potential Use of a Rapid Point-of-Care Device for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute Ischemic
Keywords: Large Vessels Occlusion (LVO)
Thrombectomy
Biomarkers
Point of care test (POCT)
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen Macarena
name: Hospitales Universitarios Virgen del Rocío
name: Hospital Universitario Torrecárdenas
name: Hospital Universitario Poniente
name: Hospital Clínico Universitario Lozano Blesa
name: Hospital Miguel Servet
name: Hospital Universitario Royo Villanova
name: Hospital General San Jorge
name: Hospital San Pedro de Logroño
name: Hospital Clínico Universitario de Valladolid
name: Hospital Universitario La Fe
name: Complejo Hospitalario Universitario de Albacete
name: Hospital de Medina del Campo
name: Hospital General Río Carrión
name: Hospital General de Segovia
name: Hospital del Rio Hortega
First posted: 2023-04-27
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke code activated will be recruited at a pre-hospital and hospital environment.

Brief summary: Stroke is the leading cause of long-term disability and the second most common cause of death worldwide. Currently, the protocols require the imaging techniques at the hospitals to differ ischemic strokes with large vessel occlusion (LVO) from others. In this study, a duplex POC will be used in combination with an APP to identify LVO ischemic strokes in a 800 patients'cohort with pre-hospital and in-hospital blood samples.

Detailed description: Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. Currently, imaging techniques are required to differentiate ischemic strokes with large vessel occlusion (LVO) from others. Since those neuroimages cannot be easily done at a pre-hospital level, our objective is to develop a simple point-of-care test (POC) to differentiate between both ischemic strokes during the acute phase, which will allow in the future an earlier thrombectomy treatment and an improvement of the patient outcomes significantly. For that, the investigators will recruit a 800 patients' cohort with pre-hospital and in-hospital blood samples by a multiplex POC for the biomarker measurement using an APP in combination with clinical data to identify LVO ischemic strokes. Finally, an interim analysis is planned when 400 patients are recruited.

Eligibility criteria: Inclusion Criteria:

* I.1: Patients \> 18 years old.
* I.2: Stroke code activated.
* 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: Previous diagnosis different from stroke.
* E.2: Impossibility of getting a blood sample.
* E.3: Refusal to provide the informed consent by the patient/relative.

Primary outcomes:
measure: Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)
timeFrame: 6 months
Secondary outcomes:
measure: Viability of the implement of the tool at a pre-hospital environment
timeFrame: 6 months
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario Albacete
city: Almería
country: Spain
facility: Hospital Universitario Poniente
city: Almería
country: Spain
facility: Hospital Universitario Torrecárdenas
city: Huesca
country: Spain
facility: Hospital General San Jorge
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Palencia
country: Spain
facility: Hospital General Río Carrión
city: Segovia
country: Spain
facility: Hospital General de Segovia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Rocío
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Valladolid
country: Spain
facility: Hospital de Medina del Campo
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Ana Barragán Prieto
role: PRINCIPAL_INVESTIGATOR
References: