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Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention

This study is currently recruiting participants.
Verified August 2012 by Maria Vittoria Hospital
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
ClinicalTrials.gov Identifier:
NCT01665495
First received: August 12, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.


Condition Intervention
Pericardial Effusion
Procedure: Extended pericardial drainage by catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.

Resource links provided by NLM:


Further study details as provided by Maria Vittoria Hospital:

Primary Outcome Measures:
  • Recurrent pericardial effusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Need for repeated pericardiocentesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Need for cardiac surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Disease-related hospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Complication rates [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up


Estimated Enrollment: 122
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pericardiocentesis
Pericardial fluid drained by simple echo-guided pericardiocentesis
Active Comparator: Extended pericardial drainage
Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return<30ml
Procedure: Extended pericardial drainage by catheter
Extended pericardial drainage will be done after pericardiocentesis by the insertion of a catheter to intermittently drain pericardial fluid till daily fluid return<30 ml.

Detailed Description:

The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients
  • pericardial effusion requiring pericardiocentesis
  • non-malignant etiology

Exclusion Criteria:

  • known neoplastic etiology
  • known bacterial etiology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665495

Contacts
Contact: Massimo Imazio, MD FESC +390114393391 massimo_imazio@yahoo.it
Contact: Riccardo Belli, MD FESC +390114393557

Locations
Italy
Ospedali Riuniti Recruiting
Bergamo, Italy
Contact: Antonio Brucato, MD         
Principal Investigator: Antonio Brucato, MD         
Ospedale Regionale San Maurizio Active, not recruiting
Bolzano, Italy
Ospedale Niguarda Recruiting
Milan, Italy
Contact: Anna Gandino, MD         
Principal Investigator: Anna Gandino, MD         
Ospedale degli Infermi Active, not recruiting
Rivoli, Italy
Ospedale Mauriziano Active, not recruiting
Torino, Italy
Cardiology Department, Maria Vittoria Hospital Recruiting
Torino, Italy
Contact: Massimo Imazio, MD,FESC    +39 0114393391      
Principal Investigator: Massimo Imazio, MD FESC         
Sub-Investigator: Riccardo Belli, MD         
Sub-Investigator: Massimo Giammaria, MD         
Sub-Investigator: Federico Beqeraj, MD         
Cardiology Department, Ospedale San Giovanni Bosco Recruiting
Torino, Italy
Contact: Massimo Minelli, MD         
Principal Investigator: Massimo Minelli, MD         
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
Principal Investigator: Massimo Imazio, MD Cardiology Department, Maria Vittoria Hospital
  More Information

No publications provided

Responsible Party: Massimo Imazio, Cardiologist, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01665495     History of Changes
Other Study ID Numbers: 72/16/11
Study First Received: August 12, 2012
Last Updated: August 14, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Maria Vittoria Hospital:
pericardial effusion
cardiac tamponade
pericardiocentesis
pericardial drainage
prevention

Additional relevant MeSH terms:
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014