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

This study is currently recruiting participants. (see Contacts and Locations)
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

August 12, 2012
August 14, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01665495 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
Same as current
 
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pericardial Effusion
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.
  • 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
    Intervention: Procedure: Extended pericardial drainage by catheter
Imazio M, Belli R, Beqaraj F, Giammaria M, Lestuzzi C, Hoit B, LeWinter M, Spodick DH, Adler Y; DROP Investigators. DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention: rationale and design of the DROP trial, a randomized, open-label, multicenter study. J Cardiovasc Med (Hagerstown). 2014 Jun;15(6):510-4. doi: 10.2459/JCM.0b013e3283621d26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
122
December 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • known neoplastic etiology
  • known bacterial etiology
Both
18 Years to 90 Years
No
Contact: Massimo Imazio, MD FESC +390114393391 massimo_imazio@yahoo.it
Contact: Riccardo Belli, MD FESC +390114393557
Italy
 
NCT01665495
72/16/11
Yes
Massimo Imazio, Maria Vittoria Hospital
Maria Vittoria Hospital
Not Provided
Principal Investigator: Massimo Imazio, MD Cardiology Department, Maria Vittoria Hospital
Maria Vittoria Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP