Clinical Trial: Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
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.
Detailed Summary: 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.
Sponsor: Maria Vittoria Hospital
Current Primary Outcome:
- Recurrent pericardial effusion [ Time Frame: 12 months ]
- Need for repeated pericardiocentesis [ Time Frame: 12 months ]
- Need for cardiac surgery [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Hospital stay [ Time Frame: 12 months ]
- Disease-related hospitalization [ Time Frame: 12 months ]
- Overall mortality [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Maria Vittoria Hospital
Dates:
Date Received: August 12, 2012
Date Started: December 2011
Date Completion: December 2014
Last Updated: August 14, 2012
Last Verified: August 2012
