Pericardial Effusion
Conditions
Keywords
pericardial effusion, cardiac tamponade, pericardiocentesis, pericardial drainage, prevention
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.
Interventions
PROCEDUREExtended 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.
Sponsors
Maria Vittoria Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* adult patients * pericardial effusion requiring pericardiocentesis * non-malignant etiology
Exclusion criteria
* known neoplastic etiology * known bacterial etiology
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need for cardiac surgery | 12 months |
| Recurrent pericardial effusion | 12 months |
| Need for repeated pericardiocentesis | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall mortality | 12 months |
| Hospital stay | 12 months |
| Disease-related hospitalization | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complication rates | 12 months | Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up |
Countries
Italy
Contacts
Primary ContactMassimo Imazio, MD FESC
Backup ContactRiccardo Belli, MD FESC
Outcome results
None listed