Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy

Acute Ischemic Stroke Clinical Trial

— TROMBOPOCT  

Official title:

Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06467396
• Other study ID #: TROMBOPOCT
• Status: Recruiting
• Start date: April 9, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Rosa M Delgado
• Phone: 955923067
• Email: trainingbioship[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

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. The socio-economical cost of the stroke is very high, being around 45 million euros per year in Europe. Although mechanical thrombectomy is the most effective treatment for stroke patients with large vessel occlusions still a large percentage of patients, around 50%, do not recover despite a successful recanalization (the so called "futile recanalization"). Therefore, to anticipate the prognosis of patients treated with mechanical thrombectomy would be clinically relevant and very informative.

This observational study evaluates the precision of a rapid test of blood biomarkers in the prognosis of stroke patients treated by mechanical thrombectomy. For that, the investigators will recruit a cohort of 400 consecutive patients treated by thrombectomy. Using a multiplex POC for the biomarker measurement and an APP in combination with clinical data, the potential of biomarkers to predict the prognosis of a patient will be determined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years old.

• Patient in whom a mechanical thrombectomy is performed.

Exclusion Criteria:

• Impossibility of getting a blood sample.

• Impossibility of performing the test (Invalid results)

• Refusal to provide the informed consent by the patient/relative.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• Large Vessel Occlusion Biomarkers Test
Duplex Point of Care test to measure the concentration of blood biomarkers (FABP+NT-proBNP) associated to Large Vessel Occlusion in blood samples used in combination with an APP.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen Rocío	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Hospital Universitario Reina Sofia de Cordoba, Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity and sensibility of blood biomarkers in combination with neurological scales (NIHSS) determined before the thrombectomy intervention to predict the prognosis of the patient (functional dependence and mortality).		through the study completion, an average of one year
Secondary	Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy.		3 months