NCT05833945

Potential Use of a POCT for the Direct Transfer of Stroke Patients From the Ambulance to the Thrombectomy Center

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 355 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
DEVICE	Large Vessel Occlusion Biomarkers Test	Duplex Point of Care test to measure the concentration of biomarkers associated to Large Vessel Occlusion in blood samples used in combination with an APP.

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-01-31
• Completion: 2024-04-24
• First posted: 2023-04-27
• Last updated: 2024-11-18

Locations

16 sites across 1 country: Spain