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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Device: Large Vessel Occlusion Biomarkers Test

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.

• Study Type: Observational
• Enrollment (Actual): 355

Contacts and Locations

Study Locations

• Spain
  • Albacete, Spain
    • Complejo Hospitalario Universitario Albacete
  • Almería, Spain
    • Hospital Universitario Torrecárdenas
  • Almería, Spain
    • Hospital Universitario Poniente
  • Huesca, Spain
    • Hospital General San Jorge
  • Logroño, Spain
    • Hospital San Pedro
  • Palencia, Spain
    • Hospital General Río Carrión
  • Segovia, Spain
    • Hospital General de Segovia
  • Sevilla, Spain
    • Hospital Universitario Virgen Macarena
  • Sevilla, Spain
    • Hospital Universitario Virgen Rocio
  • Valencia, Spain
    • Hospital la Fé
  • Valladolid, Spain
    • Hospital Universitario Rio Hortega
  • Valladolid, Spain
    • Hospital Clínico de Valladolid
  • Valladolid, Spain
    • Hospital de Medina del Campo
  • Zaragoza, Spain
    • Hospital Miguel Servet
  • Zaragoza, Spain
    • Hospital Clínico Universitario Lozano Blesa
  • Zaragoza, Spain
    • Hospital Royo Villanova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with stroke code activated will be recruited at a pre-hospital and hospital environment.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-hospital and in-hospital patients; Patients recruited at the ambulance (ARM A) and at the hospital (ARM B).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the diagnosis accuracy of the algorithm LVOCheck (Specificity and sensibility)	Biomarkers; Clinical data (gender, age, diabetes, dyslipidemia, atrial fibrillation, blood pressure); Neurologic scales (NIHSS, RACE, GFAST, Cincinatti)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viability of the implement of the tool at a pre-hospital environment	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.	6 months

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: Hospital Universitario Virgen Macarena; Hospital Universitario La Fe; Complejo Hospitalario Universitario de Albacete; Hospitales Universitarios Virgen del Rocío; Hospital del Rio Hortega; Hospital Miguel Servet; Hospital Clínico Universitario de Valladolid; Hospital General de Segovia; Hospital Clínico Universitario Lozano Blesa; Hospital Universitario Torrecárdenas; Hospital General San Jorge; Hospital Universitario Poniente; Hospital Universitario Royo Villanova; Hospital San Pedro de Logroño; Hospital de Medina del Campo; Hospital General Río Carrión
• Investigators: Principal Investigator: Ana Barragán Prieto, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): April 24, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Thrombectomy; Biomarkers; Large Vessels Occlusion (LVO); Point of care test (POCT)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: BIOSHIP-training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) might be included in a publication. Specific data set are not determined yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No