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NCT Number: NCT01127984

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

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Key information

Conditions

Pacemaker Implantation Antiplatelet Therapy or Oral Anticoagulants Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Pocket Hematoma and Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Invasive Cardiology 1, Careggi Hospital

Florence, 50134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

tissucol

Drug

dosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes

Other names: local tissucol application

drainage system

Procedure

application of vacuum drainage system

Other names: vacuum drainage system

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Careggi Hospital

Other

Registry information

Official study 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.

Acronym: PHP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
Registry last updated
Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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