Clinical trial NCT03067909: Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry
Official title: THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Device Related Infection
Antithrombotic Drugs
Cardiac Arrhythmia
Surgery--Complications
Hematoma
Lead sponsor: Azienda Ospedaliera Universitaria Senese
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 1450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients taking antithrombotic therapy undergoing CIED surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinically significant pocket hematoma
timeFrame: One month
Secondary outcomes:
measure: Non-clinically significant pocket hematoma
timeFrame: One month
measure: Hemorrhagic complications other than pocket hematoma
timeFrame: One month
measure: Thromboembolic complications
timeFrame: Twelve months
measure: All cause death
timeFrame: Twelve months
measure: CIED-related infection
timeFrame: Twelve months
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOU Senese
Study officials:
affiliation: AOU Senese
name: Valerio Zacà, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaca 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.
citation: 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