Potential Use of a POCT for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center
- Conditions
- Stroke, Acute Ischemic
- Interventions
- Device: Large Vessel Occlusion Biomarkers Test
- Registration Number
- NCT05833945
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pre-hospital and in-hospital patients Large Vessel Occlusion Biomarkers Test Patients recruited at the ambulance (ARM A) and at the hospital (ARM B).
- Primary Outcome Measures
Name Time Method Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility) 6 months * Biomarkers
* Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure)
* Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)
- Secondary Outcome Measures
Name Time Method Viability of the implement of the tool at a pre-hospital environment 6 months * Estimated time in patients direct potentially transferred to the thrombectomy centers.
* Error rate in tool performance at a pre-hospital and hospital environment.
* Percentage of right use of the tool (human failares) at a pre-hospital and hospital environment.
Trial Locations
- Locations (16)
Hospital Universitario Torrecárdenas
🇪🇸Almería, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Complejo Hospitalario Universitario Albacete
🇪🇸Albacete, Spain
Hospital Universitario Poniente
🇪🇸Almería, Spain
Hospital General San Jorge
🇪🇸Huesca, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital General Río Carrión
🇪🇸Palencia, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital General de Segovia
🇪🇸Segovia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Universitario Virgen Rocío
🇪🇸Sevilla, Spain
Hospital de Medina del Campo
🇪🇸Valladolid, Spain
Hospital Universitario Río Hortega
🇪🇸Valladolid, Spain
Hospital Royo Villanova
🇪🇸Zaragoza, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Spain