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Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study. (PHP)

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ClinicalTrials.gov Identifier: NCT01127984
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Careggi Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Pacemaker Implantation Pocket Hematoma and Bleeding Antiplatelet Therapy or Oral Anticoagulants Drug: tissucol Procedure: drainage system Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
Experimental: treatment with tissucol
patients treated with tissucol, local application in the pocket of PM / ICD
Drug: tissucol
dosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes
Other Name: local tissucol application
Active Comparator: vacuum drainage system
patients treated with application of vacuum drainage system.
Procedure: drainage system
application of vacuum drainage system
Other Name: vacuum drainage system



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The duration of the hospital stay [ Time Frame: 45 days after intervention ]
  2. The number of outpatient visits following the hospitalization [ Time Frame: 45 days after intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127984


Locations
Italy
Division of Invasive Cardiology 1, Careggi Hospital
Florence, Italy, 50134
Sponsors and Collaborators
Careggi Hospital
Investigators
Principal Investigator: Emilio V Dovellini, MD Division of Invasive Cardiology, Careggi Hospital

Responsible Party: Emilio Vincenzo Dovellini, MD, Careggi Hospital, Division of Invasive Cardiology 1, Florence, Italy
ClinicalTrials.gov Identifier: NCT01127984     History of Changes
Other Study ID Numbers: DOVE 1
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: May 2010

Keywords provided by Careggi Hospital:
pacemaker
pocket haematoma
antiplatelet therapy
fibrin glue

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants