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Completed

NCT Number: NCT05833945

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complejo Hospitalario Universitario Albacete, Albacete, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Large Vessel Occlusion Biomarkers Test

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.

Primary outcomes

  1. Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)

    Time frame: 6 months

    • Biomarkers
    • Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure)
    • Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)

Secondary outcomes

  1. Viability of the implement of the tool at a pre-hospital environment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Complejo Hospitalario Universitario de Albacete
  • Hospital Clínico Universitario Lozano Blesa
  • Hospital Clínico Universitario de Valladolid
  • Hospital General Río Carrión
  • Hospital General San Jorge
  • Hospital General de Segovia
  • Hospital Miguel Servet
  • Hospital San Pedro de Logroño
  • Hospital Universitario La Fe
  • Hospital Universitario Poniente
  • Hospital Universitario Royo Villanova
  • Hospital Universitario Torrecárdenas
  • Hospital Universitario Virgen Macarena
  • Hospital de Medina del Campo
  • Hospital del Rio Hortega
  • Hospitales Universitarios Virgen del Rocío

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2023
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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