Pacemaker ImplantationPhase 4PHPNCT01127984
Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study.
A Phase 4 study testing tissucol and drainage system in people with Pacemaker Implantation and Pocket Hematoma and Bleeding, run by Careggi Hospital at 1 site in Italy.
Trial summary
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- What is being tested?
- tissucol and drainage system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Jan 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who require an initial implantation or replacement of a device (pacemaker, biventricular pacemaker, implantable cardiac defibrillator) treated with:
- Dual antiplatelet therapy (i.e. ASA and clopidogrel, ASA and prasugrel) or
- Anticoagulant therapy (warfarin, heparin, LMWH).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator (ICD) During Dual Antiplatelet or Anticoagulant Therapy. A Prospective Randomized Trial. The PHP Study.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low molecular weight heparin).
Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005 Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving anticoagulant treatment.
Read more
Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days before the intervention. This practice may result in a high risk of thrombotic events in patients with coronary stenting.
Recently, in our Center we started the use of a fibrin sealant for local haemostasis (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket haematoma complication, the need of vacuum drainage system, and the reduction of hospital stay.
Read the detailed description
Purpose of the study. The purpose of this study is to demonstrate the efficacy of a fibrin sealant (Tissucol-Baxter) in prevention pocket haematoma and subsequent complications in patients who required implantation/replacement of a pacemaker or ICD wich cannot discontinue dual antiplatelet or anticoagulant therapy.
Target. The primary endpoint is to test the impact of pocket haematoma in patients treated with tissucol compared to a conventional treatment with vacuum drainage system without dual antiplatelet or anticoagulant therapy discontinuation.
The secondary endpoint is to compare the length of hospitalization between the two groups.
Type of study. Prospective, randomized, single center, open label.
Materials and methods. Will be consecutively enrolled approximately 100 patients.
Inclusion criteria: patients over the age of eighteen who require an initial implantation or replacement of a device (pacemaker, biventricular pacemaker, ICD) treated with:
- dual antiplatelet therapy (clopidogrel or prasugrel or ticlopidine, and acetylsalicylic acid) or
- anticoagulants (warfarin or heparin or low molecular weight heparin). Patients Do not discontinue the antiplatelet or anticoagulant therapy.
According to a randomization list, patients will be assigned to tissucol treatment or vacuum drainage system:
- 50 patients: treated with local application of tissucol in the pocket of pacemaker/ICD;
- 50 patients: treated with vacuum drainage system.
- Conditions
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- Being tested
- tissucol, drainage system
- Keywords
- pacemaker, pocket haematoma, antiplatelet therapy, fibrin glue
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissucolDrug
Also called local tissucol application
dosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes
drainage systemProcedure or surgery
Also called vacuum drainage system
application of vacuum drainage system
| Study group | Role | What they receive |
|---|---|---|
| treatment with tissucol | Experimental | patients treated with tissucol, local application in the pocket of PM / ICD Receives: Drug: tissucol |
| vacuum drainage system | Active comparator | patients treated with application of vacuum drainage system. Receives: Procedure: drainage system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of pocket device: haematoma and bleeding.Pocket haematoma is defined as palpable swelling of the device pocket exceeding the size of the generator.Bleeding is defined as > 100 ml amount of fluid collected in the drainage system.
Measured: 45 days after intervention
Secondary outcomes (2)
The duration of the hospital stay
Measured: 45 days after intervention
The number of outpatient visits following the hospitalization
Measured: 45 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker ImplantationStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Emilio V Dovellini, MD, Principal investigator, Division of Invasive Cardiology, Careggi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127984
- Sponsor's protocol ID
- DOVE 1
- Acronym
- PHP
- Status last verified
- May 2010
- First submitted
- 20 May 2010
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator (ICD) During Dual Antiplatelet or Anticoagulant Therapy. A Prospective Randomized Trial. The PHP Study.
- ClinicalTrials.gov ID
- NCT01127984
- Acronym / sponsor ID
- PHP / DOVE 1
- Conditions
- Pacemaker Implantation, Pocket Hematoma and Bleeding, Antiplatelet Therapy or Oral Anticoagulants
- Keywords
- pacemaker, pocket haematoma, antiplatelet therapy, fibrin glue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 May 2010 (estimated)
- 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.
The aim of this study is to demonstrate the efficacy of fibrin sealant (Tissucol-Baxter) in preventing pocket haematoma and subsequent complications in patients undergoing pacemaker or ICD implantation/replacement which cannot discontinue dual antiplatelet therapy (i.e. ASA and clopidogrel, ASA and prasugrel) or anticoagulant therapy (i.e. warfarin, heparin, low molecular weight heparin).
Fibrin-based sealant is available for local haemostasis. A recent study (Milic DJ et al, 2005 Europace, 7: 374-379) has shown the efficacy of the fibrin sealant in prevention of pacemaker pocket haematoma in 40 patients undergoing pacemaker implantation who are receiving anticoagulant treatment.
Patients with dual antiplatelet therapy (DAT) are prone to a high risk of bleeding during surgical procedures. Thus, the routine use is the discontinuation of DAT al least 4-7 days before the intervention. This practice may result in a high risk of thrombotic events in patients with coronary stenting.
Recently, in our Center we started the use of a fibrin sealant for local haemostasis (Tissucol Baxter), and the investigators observed a reduction in the incidence of pocket haematoma complication, the need of vacuum drainage system, and the reduction of hospital stay.
Detailed description
Purpose of the study. The purpose of this study is to demonstrate the efficacy of a fibrin sealant (Tissucol-Baxter) in prevention pocket haematoma and subsequent complications in patients who required implantation/replacement of a pacemaker or ICD wich cannot discontinue dual antiplatelet or anticoagulant therapy.
Target. The primary endpoint is to test the impact of pocket haematoma in patients treated with tissucol compared to a conventional treatment with vacuum drainage system without dual antiplatelet or anticoagulant therapy discontinuation.
The secondary endpoint is to compare the length of hospitalization between the two groups.
Type of study. Prospective, randomized, single center, open label.
Materials and methods. Will be consecutively enrolled approximately 100 patients.
Inclusion criteria: patients over the age of eighteen who require an initial implantation or replacement of a device (pacemaker, biventricular pacemaker, ICD) treated with:
- dual antiplatelet therapy (clopidogrel or prasugrel or ticlopidine, and acetylsalicylic acid) or
- anticoagulants (warfarin or heparin or low molecular weight heparin). Patients Do not discontinue the antiplatelet or anticoagulant therapy.
According to a randomization list, patients will be assigned to tissucol treatment or vacuum drainage system:
- 50 patients: treated with local application of tissucol in the pocket of pacemaker/ICD;
- 50 patients: treated with vacuum drainage system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with tissucol | Experimental | Drug: tissucolpatients treated with tissucol, local application in the pocket of PM / ICD |
| vacuum drainage system | Active comparator | Procedure: drainage systempatients treated with application of vacuum drainage system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who require an initial implantation or replacement of a device (pacemaker, biventricular pacemaker, implantable cardiac defibrillator) treated with:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| tissucolAlso: local tissucol applicationdosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes | Drug | treatment with tissucol |
| drainage systemAlso: vacuum drainage systemapplication of vacuum drainage system | Procedure or surgery | vacuum drainage system |
Primary outcome
Complications of pocket device: haematoma and bleeding.Pocket haematoma is defined as palpable swelling of the device pocket exceeding the size of the generator.Bleeding is defined as > 100 ml amount of fluid collected in the drainage system.
Time frame: 45 days after intervention
2 secondary outcomes
The duration of the hospital stay
Time frame: 45 days after intervention
The number of outpatient visits following the hospitalization
Time frame: 45 days after intervention
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 11 Feb 2011.
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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.
Emilio V Dovellini, MD principal investigator
Division of Invasive Cardiology, Careggi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tissucol and drainage system in people with Pacemaker Implantation and Pocket Hematoma and Bleeding, run by Careggi Hospital 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 0 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 11 Feb 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complications of pocket device: haematoma and bleeding.Pocket haematoma is defined as palpable swelling of the device pocket exceeding the size of the generator.Bleeding is defined as > 100 ml amount of fluid collected in the drainage system. (time frame: 45 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2011.