Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06467396
Other study ID # TROMBOPOCT
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06113848 - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy Phase 3
Completed NCT04069546 - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency N/A
Active, not recruiting NCT05700097 - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy Phase 2
Recruiting NCT06058130 - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis N/A
Recruiting NCT04415164 - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke Phase 4
Recruiting NCT05363397 - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke Phase 2
Completed NCT05429658 - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System N/A
Recruiting NCT05390580 - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct N/A
Enrolling by invitation NCT05515393 - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke Phase 2
Active, not recruiting NCT05070260 - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo Phase 2/Phase 3
Terminated NCT05547412 - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed NCT03366818 - New Stent Retriever, VERSI System for AIS N/A
Not yet recruiting NCT06040476 - Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS) Phase 2
Not yet recruiting NCT06437431 - Glenzocimab in Anterior Stroke With Large Ischemic Core Eligible for Endovascular Therapy Phase 2/Phase 3
Not yet recruiting NCT05293080 - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Phase 3
Completed NCT02223273 - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) N/A
Completed NCT02586233 - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke Phase 1/Phase 2
Terminated NCT01694381 - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor Early Phase 1
Not yet recruiting NCT01594190 - Physical Activity Immediately After Acute Cerebral Ischemia N/A
Completed NCT01120301 - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) Phase 3