Platelet Function and Neurological Events
- Conditions
- Carotid Artery DiseasesStroke, Acute
- Registration Number
- NCT05572320
- Lead Sponsor
- Scientific Institute San Raffaele
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 386
- Age > 18 years
- Carotid Artery Diseases undergoing carotid thrombendarterectomy
- Signed consent
- Atrial fibrillation
- New oral anticoagulant
- Oral Vitamin k inhibitors
- Platelet count <80000 per microliter
- Ongoing ischemic stroke
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TRAP, ADP and ASPI thresholds to predict neurological events immediately before the surgery It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events
Platelet function and neurological events immediately before the surgery 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
- Secondary Outcome Measures
Name Time Method 6 months and 1 year neurological events 6 months and 1 year Occurrence of neurological events after 6 months and 1 year after the procedure
Occurrence of any complications within 1 month of patients' enrolled or before the hospital discharge Occurrence of surgical and medical complications
6 months and 1 year mortality 6 months and 1 year Mortality at 6 months and 1 years after carotid surgery
Occurence of thromboembolic neurological events within 1 month of patients' enrolled or before the hospital discharge
Trial Locations
- Locations (1)
Scientific Institute San Raffaele
🇮🇹Milan, Italy