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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03067909
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Valerio Zacà, Azienda Ospedaliera Universitaria Senese

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.

Condition or disease Intervention/treatment
Device Related Infection Antithrombotic Drugs Cardiac Arrhythmia Surgery--Complications Hematoma Other: CIED surgery

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
Patients undergoing CIED surgery
Patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy (either or both antiplatelet agents and/or anticoagulants).
Other: CIED surgery

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients taking antithrombotic therapy undergoing CIED surgery.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03067909

Contact: Valerio Zacà, MD

AOU Senese Recruiting
Siena, Italy, 53100
Contact: Valerio Zaca', MD         
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Senese
Principal Investigator: Valerio Zacà, MD AOU Senese

Responsible Party: Valerio Zacà, Principal Investigator, Cardiology Consultant, Arrhythmology Unit, Cardiothoracic and Vascular Department, Azienda Ospedaliera Universitaria Senese Identifier: NCT03067909     History of Changes
Other Study ID Numbers: HNM_V1
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be made available on demand to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Prosthesis-Related Infections
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Postoperative Complications