Device Related InfectionNCT03067909
Antithrombotic Therapy in Patients Undergoing CIED Surgery - HEMATOMA NO MORE Registry
An observational study of Device Related Infection and Antithrombotic Drugs, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Related Infection, Antithrombotic Drugs, Cardiac Arrhythmia
- What is being tested?
- CIED surgery
- How many people
- 1,450 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Dec 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients taking antithrombotic therapy undergoing CIED surgery.
Who may be able to join
- 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
Who cannot join
- Patient with life expectancy less than 12 months as per investigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Device Related Infection, Antithrombotic Drugs, Cardiac Arrhythmia, Surgery--Complications, Hematoma
- Being tested
- CIED surgery
- Medical subject headings
- Prosthesis-Related Infections, Arrhythmias, Cardiac, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIED surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing CIED surgery | Patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy (either or both antiplatelet agents and/or anticoagulants). Receives: Other: CIED surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One month
Secondary outcomes (5)
Non-clinically significant pocket hematoma
Post-procedural hematoma not meeting diagnostic criteria for clinically significant
Measured: One month
Hemorrhagic complications other than pocket hematoma
Hemothorax, cardiac tamponade, pericardial effusion, intracranial hemorrhage
Measured: One month
Thromboembolic complications
Transient ischemic attack, ischemic stroke, deep venous thrombosis, pulmonary embolism, systemic embolic event, acute myocardial infarction, prosthetic cardiac valve thrombosis
Measured: Twelve months
All cause death
Measured: Twelve months
CIED-related infection
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study startMay 2016
- Primary completionSep 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Device Related InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,450 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerio Zacà, Azienda Ospedaliera Universitaria Senese
- Investigators
- Valerio Zacà, MD, Principal investigator, AOU Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067909
- Sponsor's protocol ID
- HNM_V1
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available on demand to other researchers.
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.
PubMed 28594654V 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 at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE Management of AntiThrOMbotic therApy in Patients Undergoing Electrophysiological Device Surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE)
- ClinicalTrials.gov ID
- NCT03067909
- Acronym / sponsor ID
- HNM_V1
- Conditions
- Device Related Infection, Antithrombotic Drugs, Cardiac Arrhythmia, Surgery--Complications, Hematoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing CIED surgery | – | Other: CIED surgeryPatients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy (either or both antiplatelet agents and/or anticoagulants). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients taking antithrombotic therapy undergoing CIED surgery.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient with life expectancy less than 12 months as per investigator's judgement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CIED surgery | Other | Patients undergoing CIED surgery |
Primary outcome
Clinically significant pocket hematoma
Time frame: 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
5 secondary outcomes
Non-clinically significant pocket hematoma
Time frame: One month
Hemorrhagic complications other than pocket hematoma
Time frame: One month
Thromboembolic complications
Time frame: Twelve months
All cause death
Time frame: Twelve months
CIED-related infection
Time frame: Twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Background: PubMed 28594654Zaca 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.
- BackgroundV 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
- Individual participant dataSharing planned: Yes. IPD will be made available on demand to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerio Zacà, MD principal investigator
AOU Senese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Related Infection and Antithrombotic Drugs, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant pocket hematoma (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03067909, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.