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

NCT03067909 | Completed DMC

• 1 other identifier: HNM_V1
• Study Type: observational
• Target: 1,450
• Locations: 1 country
• Sites: 1

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.

Conditions

Device Related Infection; Antithrombotic Drugs; Cardiac Arrhythmia; Surgery--Complications; Hematoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Non-clinically significant pocket hematoma

  One month

• Hemorrhagic complications other than pocket hematoma

  One month

• Thromboembolic complications

  Twelve months

• All cause death

  Twelve months

• CIED-related infection

  Twelve months

Study Arms (1)

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

Interventions

CIED surgery OTHER

Patients undergoing CIED surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients taking antithrombotic therapy undergoing CIED surgery.

You may qualify if:

• 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

You may not qualify if:

• Patient with life expectancy less than 12 months as per investigator's judgement

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead

Study Sites (1)

AOU Senese

Siena, 53100, Italy

Location

Related Publications (2)

• 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.

  PMID: 28594654 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Prosthesis-Related Infections; Arrhythmias, Cardiac; Hematoma

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Hemorrhage

Study Officials

• Valerio Zacà, MD

  AOU Senese

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Cardiology Consultant, Arrhythmology Unit, Cardiothoracic and Vascular Department

Study Record Dates

• First Submitted: February 25, 2017
• First Posted: March 1, 2017
• Study Start: May 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)