Platelet Function and Neurological Events

Study Overview
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Brief Summary
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Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA). The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.

Detailed Description
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Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.

Official Title
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Platelet Function and Neurological Events Following Carotid Thromboendarterectomy

Conditions
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Stroke, Acute, Carotid Artery Diseases

Intervention / Treatment
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* Diagnostic Test: Platelet Aggregometry Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Carotid Artery Diseases undergoing carotid thrombendarterectomy Signed consent Exclusion Criteria: Atrial fibrillation New oral anticoagulant Oral Vitamin k inhibitors Platelet count <80000 per microliter Ongoing ischemic stroke

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Platelet Aggregometry Testing|1.6 ml of blood collected in hirudin-coated tubes before the surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet function and neurological events | The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy | immediately before the surgery | 
| TRAP, ADP and ASPI thresholds to predict neurological events | It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events | immediately before the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of thromboembolic neurological events |  | within 1 month of patients' enrolled or before the hospital discharge | 
| Occurrence of any complications | Occurrence of surgical and medical complications | within 1 month of patients' enrolled or before the hospital discharge | 
| 6 months and 1 year mortality | Mortality at 6 months and 1 years after carotid surgery | 6 months and 1 year | 
| 6 months and 1 year neurological events | Occurrence of neurological events after 6 months and 1 year after the procedure | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet function, Aggregometry, Vascular surgery, mortality, neurological events, Carotid thromboendarterectomy, Thromboembolic Stroke