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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief 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.

Detailed Summary:
Sponsor: Azienda Ospedaliera Universitaria Senese

Current Primary Outcome: Clinically significant pocket hematoma [ Time Frame: One month ]

Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Non-clinically significant pocket hematoma [ Time Frame: One month ]
    Post-procedural hematoma not meeting diagnostic criteria for clinically significant
  • Hemorrhagic complications other than pocket hematoma [ Time Frame: One month ]
    Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
  • Thromboembolic complications [ Time Frame: Twelve months ]
    Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis
  • All cause death [ Time Frame: Twelve months ]
  • CIED-related infection [ Time Frame: Twelve months ]


Original Secondary Outcome: Same as current

Information By: Azienda Ospedaliera Universitaria Senese

Dates:
Date Received: February 25, 2017
Date Started: May 2016
Date Completion: December 2018
Last Updated: February 28, 2017
Last Verified: February 2017