Trial record 2 of 5 for:    Open Studies | "Pericardial Effusion"

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
  Purpose

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.


Condition Intervention
Pericardial Effusion
Procedure: Extended pericardial drainage by catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.

Resource links provided by NLM:


Further study details as provided by Maria Vittoria Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 122
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • known neoplastic etiology
  • known bacterial etiology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665495

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

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

No publications provided by Maria Vittoria Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massimo Imazio, Cardiologist, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01665495     History of Changes
Other Study ID Numbers: 72/16/11
Study First Received: August 12, 2012
Last Updated: August 14, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Maria Vittoria Hospital:
pericardial effusion
cardiac tamponade
pericardiocentesis
pericardial drainage
prevention

Additional relevant MeSH terms:
Pericardial Effusion
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014