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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067909
• Other study ID #: HNM_V1
• Status: Completed
• Start date: May 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Antithrombotic Drugs
• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Device Related Infection
• Hematoma
• Prosthesis-Related Infections
• Surgery--Complications

Intervention

Other:
• CIED surgery

Locations

Country	Name	City	State
Italy	AOU Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Senese

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

Outcome

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