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

NCT01127984 | Completed Phase 4 DMC

• 1 other identifier: DOVE 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pacemaker Implantation; Pocket Hematoma and Bleeding; Antiplatelet Therapy or Oral Anticoagulants

Keywords

pacemaker; pocket haematoma; antiplatelet therapy; fibrin glue

Outcome Measures

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.

  45 days after intervention

Secondary Outcomes (2)

• The duration of the hospital stay

  45 days after intervention

• The number of outpatient visits following the hospitalization

  45 days after intervention

Study Arms (2)

treatment with tissucol

EXPERIMENTAL

patients treated with tissucol, local application in the pocket of PM / ICD

Drug: tissucol

vacuum drainage system

ACTIVE COMPARATOR

patients treated with application of vacuum drainage system.

Procedure: drainage system

Interventions

tissucol DRUG

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

Also known as: local tissucol application

treatment with tissucol

drainage system PROCEDURE

application of vacuum drainage system

Also known as: vacuum drainage system

vacuum drainage system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

Sponsors & Collaborators

• Careggi Hospital: lead

Study Sites (1)

Division of Invasive Cardiology 1, Careggi Hospital

Florence, 50134, Italy

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Emilio V Dovellini, MD

  Division of Invasive Cardiology, Careggi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 21, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 11, 2011

Record last verified: 2010-05

Locations

IT (1)