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

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.

Study Overview

• Status: Unknown
• Conditions: Pericardial Effusion
• Intervention / Treatment: Procedure: Extended pericardial drainage by catheter

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: Interventional
• Enrollment (Anticipated): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy
    • Recruiting
    • Ospedali Riuniti
    • Contact: Antonio Brucato, MD
    • Principal Investigator: Antonio Brucato, MD
  • Bolzano, Italy
    • Active, not recruiting
    • Ospedale Regionale San Maurizio
  • Milan, Italy
    • Recruiting
    • Ospedale Niguarda
    • Contact: Anna Gandino, MD
    • Principal Investigator: Anna Gandino, MD
  • Rivoli, Italy
    • Active, not recruiting
    • Ospedale degli Infermi
  • Torino, Italy
    • Recruiting
    • Cardiology Department, Maria Vittoria Hospital
    • Sub-Investigator: Massimo Giammaria, MD
    • Contact: Massimo Imazio, MD,FESC; Phone Number: +39 0114393391
    • Principal Investigator: Massimo Imazio, MD FESC
    • Sub-Investigator: Riccardo Belli, MD
    • Sub-Investigator: Federico Beqeraj, MD
  • Torino, Italy
    • Recruiting
    • Cardiology Department, Ospedale San Giovanni Bosco
    • Contact: Massimo Minelli, MD
    • Principal Investigator: Massimo Minelli, MD
  • Torino, Italy
    • Active, not recruiting
    • Ospedale Mauriziano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• known neoplastic etiology
• known bacterial etiology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent pericardial effusion	12 months
Need for repeated pericardiocentesis	12 months
Need for cardiac surgery	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Hospital stay	12 months
Disease-related hospitalization	12 months
Overall mortality	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rates	Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up	12 months

Collaborators and Investigators

• Sponsor: Maria Vittoria Hospital
• Investigators: Principal Investigator: Massimo Imazio, MD, Cardiology Department, Maria Vittoria Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 12, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: August 14, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: prevention; pericardiocentesis; pericardial effusion; pericardial drainage; cardiac tamponade
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pericardial Effusion
• Other Study ID Numbers: 72/16/11