Skip to main content
OpenTrials
Completed

NCT Number: NCT03067909

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Device Related Infection Antithrombotic Drugs Arrhythmias, Cardiac Cardiac Arrhythmia Cardiovascular Diseases Heart Diseases Hematoma Hemorrhage Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis-Related Infections Surgery--Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Senese

Siena, 53100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with standard indications to CIED surgery being treated with antiplatelet agents and/or anticoagulants (any commercially available device or approved and marketed drug can be included).
  • Patients able to provide written informed consent
  • Patients willing to attend the planned follow-up visits

Exclusion criteria

  • Patient with life expectancy less than 12 months as per investigator's judgement

Treatment and study plan

CIED surgery

Other

Primary outcomes

  1. 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

Secondary outcomes

  1. Non-clinically significant pocket hematoma

    Time frame: One month

    Post-procedural hematoma not meeting diagnostic criteria for clinically significant

  2. Hemorrhagic complications other than pocket hematoma

    Time frame: One month

    Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage

  3. 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

  4. All cause death

    Time frame: Twelve months

  5. CIED-related infection

    Time frame: Twelve months

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Senese

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.