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

Primary Purpose

Pericardial Effusion

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Extended pericardial drainage by catheter
Sponsored by
Maria Vittoria Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pericardial Effusion focused on measuring pericardial effusion, cardiac tamponade, pericardiocentesis, pericardial drainage, prevention

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • known neoplastic etiology
  • known bacterial etiology

Sites / Locations

  • Ospedali RiunitiRecruiting
  • Ospedale Regionale San Maurizio
  • Ospedale NiguardaRecruiting
  • Ospedale degli Infermi
  • Cardiology Department, Maria Vittoria HospitalRecruiting
  • Cardiology Department, Ospedale San Giovanni BoscoRecruiting
  • Ospedale Mauriziano

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Pericardiocentesis

Extended pericardial drainage

Arm Description

Pericardial fluid drained by simple echo-guided pericardiocentesis

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

Outcomes

Primary Outcome Measures

Recurrent pericardial effusion
Need for repeated pericardiocentesis
Need for cardiac surgery

Secondary Outcome Measures

Hospital stay
Disease-related hospitalization
Overall mortality

Full Information

First Posted
August 12, 2012
Last Updated
August 14, 2012
Sponsor
Maria Vittoria Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01665495
Brief Title
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
Acronym
DROP
Official Title
Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maria Vittoria Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion
Keywords
pericardial effusion, cardiac tamponade, pericardiocentesis, pericardial drainage, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericardiocentesis
Arm Type
No Intervention
Arm Description
Pericardial fluid drained by simple echo-guided pericardiocentesis
Arm Title
Extended pericardial drainage
Arm Type
Active Comparator
Arm Description
Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return<30ml
Intervention Type
Procedure
Intervention Name(s)
Extended pericardial drainage by catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrent pericardial effusion
Time Frame
12 months
Title
Need for repeated pericardiocentesis
Time Frame
12 months
Title
Need for cardiac surgery
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hospital stay
Time Frame
12 months
Title
Disease-related hospitalization
Time Frame
12 months
Title
Overall mortality
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Complication rates
Description
Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients pericardial effusion requiring pericardiocentesis non-malignant etiology Exclusion Criteria: known neoplastic etiology known bacterial etiology
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Imazio, MD FESC
Phone
+390114393391
Email
massimo_imazio@yahoo.it
First Name & Middle Initial & Last Name or Official Title & Degree
Riccardo Belli, MD FESC
Phone
+390114393557
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD
Organizational Affiliation
Cardiology Department, Maria Vittoria Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Riuniti
City
Bergamo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Brucato, MD
First Name & Middle Initial & Last Name & Degree
Antonio Brucato, MD
Facility Name
Ospedale Regionale San Maurizio
City
Bolzano
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Niguarda
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Gandino, MD
First Name & Middle Initial & Last Name & Degree
Anna Gandino, MD
Facility Name
Ospedale degli Infermi
City
Rivoli
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Cardiology Department, Maria Vittoria Hospital
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD,FESC
Phone
+39 0114393391
First Name & Middle Initial & Last Name & Degree
Massimo Imazio, MD FESC
First Name & Middle Initial & Last Name & Degree
Riccardo Belli, MD
First Name & Middle Initial & Last Name & Degree
Massimo Giammaria, MD
First Name & Middle Initial & Last Name & Degree
Federico Beqeraj, MD
Facility Name
Cardiology Department, Ospedale San Giovanni Bosco
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Minelli, MD
First Name & Middle Initial & Last Name & Degree
Massimo Minelli, MD
Facility Name
Ospedale Mauriziano
City
Torino
Country
Italy
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
23867908
Citation
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.
Results Reference
derived

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

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