Pacemaker Implantation Clinical Trial
— PHPOfficial 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.
Verified date | May 2010 |
Source | Careggi Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Division of Invasive Cardiology 1, Careggi Hospital | Florence |
Lead Sponsor | Collaborator |
---|---|
Careggi Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 45 days after intervention | Yes | |
Secondary | The duration of the hospital stay | 45 days after intervention | Yes | |
Secondary | The number of outpatient visits following the hospitalization | 45 days after intervention | Yes |
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