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

THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications; Cardiac Arrhythmia; Hematoma; Device Related Infection; Antithrombotic Drugs
• Intervention / Treatment: Other: CIED surgery

• Study Type: Observational
• Enrollment (Actual): 1450

Contacts and Locations

Study Locations

• Italy
  • Siena, Italy, 53100
    • AOU Senese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients taking antithrombotic therapy undergoing CIED surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Senese
• Investigators: Principal Investigator: Valerio Zacà, MD, AOU Senese

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 25, 2017
• First Submitted That Met QC Criteria: February 25, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 7, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Postoperative Complications; Hemorrhage; Arrhythmias, Cardiac; Prosthesis-Related Infections; Hematoma
• Other Study ID Numbers: HNM_V1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be made available on demand to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No