Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
DROP
1 other identifier
interventional
122
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 12, 2012
CompletedFirst Posted
Study publicly available on registry
August 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 15, 2012
August 1, 2012
2 years
August 12, 2012
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recurrent pericardial effusion
12 months
Need for repeated pericardiocentesis
12 months
Need for cardiac surgery
12 months
Secondary Outcomes (3)
Hospital stay
12 months
Disease-related hospitalization
12 months
Overall mortality
12 months
Other Outcomes (1)
Complication rates
12 months
Study Arms (2)
Pericardiocentesis
NO INTERVENTIONPericardial fluid drained by simple echo-guided pericardiocentesis
Extended pericardial drainage
ACTIVE COMPARATORExtended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return\<30ml
Interventions
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
You may qualify if:
- adult patients
- pericardial effusion requiring pericardiocentesis
- non-malignant etiology
You may not qualify if:
- known neoplastic etiology
- known bacterial etiology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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
Related Publications (1)
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.
PMID: 23867908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Massimo Imazio, MD
Cardiology Department, Maria Vittoria Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
August 12, 2012
First Posted
August 15, 2012
Study Start
December 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
August 15, 2012
Record last verified: 2012-08