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

Completed

• Conditions: Device Related Infection; Antithrombotic Drugs; Surgery--Complications; Hematoma; Cardiac Arrhythmia
• Interventions: Other: CIED surgery

• Registration Number: NCT03067909
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2017-02-25
• Study First Submitted QC: 2017-02-25
• Study First Posted: 2017-03-01
• Primary Completion: 2017-09
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Clinically significant pocket hematoma	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

Name	Time	Method
Non-clinically significant pocket hematoma	One month	Post-procedural hematoma not meeting diagnostic criteria for clinically significant
Hemorrhagic complications other than pocket hematoma	One month	Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
Thromboembolic complications	Twelve months	Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis
All cause death	Twelve months
CIED-related infection	Twelve months

Trial Locations

Locations (1)

AOU Senese; 🇮🇹 Siena, Italy