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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06467396

Acronym

TROMBOPOCT

Enrollment

400

Registered

2024-06-21

Start date

2024-04-09

Completion date

2025-07-31

Last updated

2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

Large Vessel Occlusion Biomarkers Test, Thrombectomy

Brief 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.

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.

Interventions

DEVICELarge 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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).	through the study completion, an average of one year

Secondary

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

Countries

Spain

Contacts

Primary ContactRosa M Delgado

trainingbioship@gmail.com955923067

Backup ContactCarmen De Jesús Gil