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

Not Applicable

• Conditions: Pericardial Effusion
• Interventions: Procedure: Extended pericardial drainage by catheter

• Registration Number: NCT01665495
• Lead Sponsor: Maria Vittoria Hospital

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 Timeline

• Study Start: 2011-12
• Status Verified: 2012-08
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

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

Exclusion Criteria

• known neoplastic etiology
• known bacterial etiology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extended pericardial drainage	Extended pericardial drainage by catheter	Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return\<30ml

Primary Outcome Measures

Name	Time	Method
Recurrent pericardial effusion	12 months
Need for cardiac surgery	12 months
Need for repeated pericardiocentesis	12 months

Secondary Outcome Measures

Name	Time	Method
Overall mortality	12 months
Hospital stay	12 months
Disease-related hospitalization	12 months

Trial Locations

Locations (7)

Ospedale Regionale San Maurizio; 🇮🇹 Bolzano, Italy

Ospedali Riuniti; 🇮🇹 Bergamo, Italy

Ospedale Niguarda; 🇮🇹 Milan, Italy

Ospedale degli Infermi; 🇮🇹 Rivoli, Italy

Cardiology Department, Maria Vittoria Hospital; 🇮🇹 Torino, Italy

Ospedale Mauriziano; 🇮🇹 Torino, Italy

Cardiology Department, Ospedale San Giovanni Bosco; 🇮🇹 Torino, Italy