NCT03067909

Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry

THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,450 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Senese · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hundreds of thousands patients undergo implantation or replacement of cardiac implantable electronic devices (CIEDs) annually in Europe, and up to 50% of these subjects receive antiplatelet agents or oral anticoagulants. Antithrombotic therapy increases the risk of developing pocket hematoma which in turn is associated with an increased risk of potentially fatal device-related infections when clinically significant. Aim of the registry is to retrospectively (pilot local registry in Tuscany) and prospectively (multicenter national registry in Italy) investigate the different strategies for the management of antithrombotic therapy and the related complication rates (1-month and 12-months) in patients undergoing CIED surgery in a real-world setting. The registry will also provide data on the economic impact of different management strategies and complications.

Conditions

• Device Related Infection
• Antithrombotic Drugs
• Cardiac Arrhythmia
• Surgery--Complications
• Hematoma

Interventions

Type	Name	Description
OTHER	CIED surgery

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-09-01
• Completion: 2018-12-01
• First posted: 2017-03-01
• Last updated: 2019-02-08

Locations

1 site across 1 country: Italy