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

This study has been completed.
Sponsor:
Information provided by:
Careggi Hospital
ClinicalTrials.gov Identifier:
NCT01127984
First received: May 20, 2010
Last updated: February 10, 2011
Last verified: May 2010

May 20, 2010
February 10, 2011
December 2009
January 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01127984 on ClinicalTrials.gov Archive Site
  • The duration of the hospital stay [ Time Frame: 45 days after intervention ] [ Designated as safety issue: Yes ]
  • The number of outpatient visits following the hospitalization [ Time Frame: 45 days after intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pocket Haematoma Prevention in Patients Who Required Implantation/Replacement of a Pacemaker or Implantable Cardiac Defibrillator. The PHP Study.
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.

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pacemaker Implantation
  • Pocket Hematoma and Bleeding
  • Antiplatelet Therapy or Oral Anticoagulants
  • Drug: tissucol
    dosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes
    Other Name: local tissucol application
  • Procedure: drainage system
    application of vacuum drainage system
    Other Name: vacuum drainage system
  • Experimental: treatment with tissucol
    patients treated with tissucol, local application in the pocket of PM / ICD
    Intervention: Drug: tissucol
  • Active Comparator: vacuum drainage system
    patients treated with application of vacuum drainage system.
    Intervention: Procedure: drainage system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2011
January 2011   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01127984
DOVE 1
Yes
Emilio Vincenzo Dovellini, MD, Careggi Hospital, Division of Invasive Cardiology 1, Florence, Italy
Careggi Hospital
Not Provided
Principal Investigator: Emilio V Dovellini, MD Division of Invasive Cardiology, Careggi Hospital
Careggi Hospital
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP