Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry
February 7, 2019 updated by: Valerio Zacà, Azienda Ospedaliera Universitaria Senese
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Siena, Italy, 53100
- AOU Senese
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinically significant pocket hematoma
Time Frame: One month
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Post-procedural hematoma resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion
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One month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-clinically significant pocket hematoma
Time Frame: One month
|
Post-procedural hematoma not meeting diagnostic criteria for clinically significant
|
One month
|
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Hemorrhagic complications other than pocket hematoma
Time Frame: One month
|
Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
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One month
|
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Thromboembolic complications
Time Frame: Twelve months
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Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis
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Twelve months
|
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All cause death
Time Frame: Twelve months
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Twelve months
|
|
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CIED-related infection
Time Frame: Twelve months
|
Twelve months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Valerio Zacà, MD, AOU Senese
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.