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

NCT ID: NCT05833945

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 355 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-15
• Study Completion Date: 2024-04-24

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.

Conditions

Stroke, Acute Ischemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pre-hospital and in-hospital patients

Patients recruited at the ambulance (ARM A) and at the hospital (ARM B).

Large Vessel Occlusion Biomarkers Test

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role: collaborator

Hospitales Universitarios Virgen del Rocío

OTHER

Sponsor Role: collaborator

Hospital Universitario Torrecárdenas

OTHER

Sponsor Role: collaborator

Hospital Universitario Poniente

UNKNOWN

Sponsor Role: collaborator

Hospital Clínico Universitario Lozano Blesa

OTHER

Sponsor Role: collaborator

Hospital Miguel Servet

OTHER

Sponsor Role: collaborator

Hospital Universitario Royo Villanova

UNKNOWN

Sponsor Role: collaborator

Hospital General San Jorge

UNKNOWN

Sponsor Role: collaborator

Hospital San Pedro de Logroño

OTHER

Sponsor Role: collaborator

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: collaborator

Hospital Universitario La Fe

OTHER

Sponsor Role: collaborator

Complejo Hospitalario Universitario de Albacete

OTHER

Sponsor Role: collaborator

Hospital de Medina del Campo

UNKNOWN

Sponsor Role: collaborator

Hospital General Río Carrión

UNKNOWN

Sponsor Role: collaborator

Hospital General de Segovia

OTHER

Sponsor Role: collaborator

Hospital del Rio Hortega

OTHER

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ana Barragán Prieto

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

Complejo Hospitalario Universitario Albacete

Albacete, , Spain

Hospital Universitario Poniente

Almería, , Spain

Hospital Universitario Torrecárdenas

Almería, , Spain

Hospital General San Jorge

Huesca, , Spain

Hospital San Pedro

Logroño, , Spain

Hospital General Río Carrión

Palencia, , Spain

Hospital General de Segovia

Segovia, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen Rocío

Seville, , Spain

Hospital La Fe

Valencia, , Spain

Hospital Clínico de Valladolid

Valladolid, , Spain

Hospital de Medina del Campo

Valladolid, , Spain

Hospital Universitario Río Hortega

Valladolid, , Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Hospital Royo Villanova

Zaragoza, , Spain

Countries

Spain

Other Identifiers

BIOSHIP-training

Identifier Type: -

Identifier Source: org_study_id