Surgery--Complications Clinical Trial
Official title:
THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)
NCT number | NCT03067909 |
Other study ID # | HNM_V1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 2018 |
Verified date | February 2019 |
Source | Azienda Ospedaliera Universitaria Senese |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient 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.
Status | Completed |
Enrollment | 1450 |
Est. completion date | December 2018 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | AOU Senese | Siena |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Senese |
Italy,
V Zaca', A Angeletti, C Baiocchi, M Bertini, M Biffi, P Busacca, M Iori, M Mezzetti, M Nesti, P Notarstefano; P3213 Real-world periprocedural management of antithrombotic therapy in patients undergoing electrophysiological device surgery: preliminary results of the HEMATOMA NO MORE, European Heart Journal, Volume 39, Issue suppl_1, 1 August 2018, ehy563.P3213, https://doi.org/10.1093/eurheartj/ehy563.P3213
Zacà V, Breschi M, Mandorli A, Panchetti L, Ricciardi G, Viani S, Notarstefano P. Rationale, study design, and pilot phase of tHE Management of AntiThrOMbotic therApy (HEMATOMA) in patients undergoing electrophysiological device surgery: Italian National Multicenter Observational REgistry. J Cardiovasc Med (Hagerstown). 2017 Nov;18(11):897-899. doi: 10.2459/JCM.0000000000000534. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinically significant pocket hematoma | Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion | One month | |
Secondary | Non-clinically significant pocket hematoma | Post-procedural hematoma not meeting diagnostic criteria for clinically significant | One month | |
Secondary | Hemorrhagic complications other than pocket hematoma | Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage | One month | |
Secondary | Thromboembolic complications | Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis | Twelve months | |
Secondary | All cause death | Twelve months | ||
Secondary | CIED-related infection | Twelve months |
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