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

Pericardial Effusion Clinical Trial

— DROP  

Official title:

Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01665495
• Other study ID #: 72/16/11
• Status: Recruiting
• Phase: N/A
• First received: August 12, 2012
• Last updated: August 14, 2012
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2012
• Source: Maria Vittoria Hospital
• Contact: Massimo Imazio, MD FESC
• Phone: +390114393391
• Email: massimo_imazio[@]yahoo.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• adult patients

• pericardial effusion requiring pericardiocentesis

• non-malignant etiology

Exclusion Criteria:

• known neoplastic etiology

• known bacterial etiology

Study Design

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

Related Conditions & MeSH terms

• Pericardial Effusion

Intervention

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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Maria Vittoria Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication rates	Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up	12 months	Yes
Primary	Recurrent pericardial effusion		12 months	No
Primary	Need for repeated pericardiocentesis		12 months	No
Primary	Need for cardiac surgery		12 months	No
Secondary	Hospital stay		12 months	No
Secondary	Disease-related hospitalization		12 months	No
Secondary	Overall mortality		12 months	No