Platelet Function and Neurological Events

NCT ID: NCT05572320

Last Updated: 2024-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

386 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2025-09-20

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.

Conditions

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Stroke, Acute Carotid Artery Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Platelet Aggregometry Testing

1.6 ml of blood collected in hirudin-coated tubes before the surgery

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Multiple Electrode Aggregometry (Multiplate) device

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scientific Institute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Fabrizio Monaco

Head of Cardiothoracic and Vascular Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fabrizio Monaco, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele Scientific Institute

Locations

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Scientific Institute San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Fabrizio Monaco, MD

Role: CONTACT

+39223467176

Fabrizio Monaco

Role: CONTACT

+39223467176

Facility Contacts

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Fabrizio Monaco, MD

Role: primary

022643 ext. 7176

References

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Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28.

Reference Type BACKGROUND
PMID: 32856558 (View on PubMed)

Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F.

Reference Type BACKGROUND
PMID: 19287328 (View on PubMed)

Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.

Reference Type BACKGROUND
PMID: 21557809 (View on PubMed)

Other Identifiers

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CE:83/INT/2022

Identifier Type: -

Identifier Source: org_study_id

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