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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2012

Last Updated Date

August 14, 2012

Start Date ^ICMJE

December 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01665495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

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

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Pericardial Effusion

Intervention ^ICMJE

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.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

122

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients
pericardial effusion requiring pericardiocentesis
non-malignant etiology

Exclusion Criteria:

known neoplastic etiology
known bacterial etiology

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01665495

Other Study ID Numbers ^ICMJE

72/16/11

Has Data Monitoring Committee

Yes

Responsible Party

Massimo Imazio, Maria Vittoria Hospital

Study Sponsor ^ICMJE

Maria Vittoria Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Massimo Imazio, MD

Cardiology Department, Maria Vittoria Hospital

Information Provided By

Maria Vittoria Hospital

Verification Date

August 2012

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

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