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

NCT03067909 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1450

Last updated 2019-02-08

No results posted yet for this study

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

OTHER

CIED surgery

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Senese

    lead OTHER

Principal Investigators

  • Valerio Zacà, MD · AOU Senese

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-09-30
Completion
2018-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03067909 on ClinicalTrials.gov