Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
This study is currently recruiting participants.
Verified August 2012 by Maria Vittoria Hospital
Sponsor:
Maria Vittoria Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 | |
| Ospedale Mauriziano | Active, not recruiting |
| Torino, 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 | |
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
| Principal Investigator: | Massimo Imazio, MD | Cardiology Department, Maria Vittoria Hospital |
More Information
No publications provided
| 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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013