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

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ClinicalTrials.gov Identifier: NCT01665495
Recruitment Status : Unknown
Verified August 2012 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was:  Recruiting
First Posted : August 15, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pericardial Effusion Procedure: Extended pericardial drainage by catheter

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Recurrent pericardial effusion [ Time Frame: 12 months ]
  2. Need for repeated pericardiocentesis [ Time Frame: 12 months ]
  3. Need for cardiac surgery [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: 12 months ]
  2. Disease-related hospitalization [ Time Frame: 12 months ]
  3. Overall mortality [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Complication rates [ Time Frame: 12 months ]
    Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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         
Ospedale Mauriziano Active, not recruiting
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
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Pericardial Effusion
Heart Diseases
Cardiovascular Diseases