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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Maria Vittoria Hospital.
Recruitment status was:  Recruiting
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665495

Locations
Italy
Ospedali Riuniti
Bergamo, Italy
Ospedale Regionale San Maurizio
Bolzano, Italy
Ospedale Niguarda
Milan, Italy
Ospedale degli Infermi
Rivoli, Italy
Cardiology Department, Maria Vittoria Hospital
Torino, Italy
Cardiology Department, Ospedale San Giovanni Bosco
Torino, Italy
Ospedale Mauriziano
Torino, Italy
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
Principal Investigator: Massimo Imazio, MD Cardiology Department, Maria Vittoria Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 December 02, 2016