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

June 20, 2024 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Overview

Status

Recruiting

Conditions

Acute Ischemic Stroke

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. 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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Rosa M Delgado
Phone Number: 955923067
Email: trainingbioship@gmail.com

Study Contact Backup

Name: Carmen De Jesús Gil
Phone Number: 955923067
Email: trainingbioship@gmail.com

Study Locations

Spain
- - Córdoba, Spain
    - Recruiting
    - Hospital Universitario Reina Sofía
    - Contact:
      
      Fernando Delgado Acosta
  - Sevilla, Spain
    - Recruiting
    - Hospital Universitario Virgen Rocio
    - Contact:
      
      Alejandro González García

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Stroke patients with large vessel occlusion treated by mechanical thrombectomy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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). Time Frame: through the study completion, an average of one year	through the study completion, an average of one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who suffer a futile recanalization after a mechanical thrombectomy. Time Frame: 3 months	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Hospital Universitario Reina Sofia de Cordoba

Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 20, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)