Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
NCT ID: NCT01665495
Last Updated: 2012-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
122 participants
INTERVENTIONAL
2011-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pericardiocentesis
Pericardial fluid drained by simple echo-guided pericardiocentesis
No interventions assigned to this group
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* pericardial effusion requiring pericardiocentesis
* non-malignant etiology
Exclusion Criteria
* known bacterial etiology
18 Years
90 Years
ALL
No
Sponsors
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Maria Vittoria Hospital
OTHER
Responsible Party
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Massimo Imazio
Cardiologist
Principal Investigators
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Massimo Imazio, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiology Department, Maria Vittoria Hospital
Locations
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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, , Italy
Countries
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Central Contacts
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Riccardo Belli, MD FESC
Role: CONTACT
Facility Contacts
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Antonio Brucato, MD
Role: primary
Anna Gandino, MD
Role: primary
Massimo Imazio, MD,FESC
Role: primary
Massimo Minelli, MD
Role: primary
References
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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.
Other Identifiers
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72/16/11
Identifier Type: -
Identifier Source: org_study_id
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