Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pericardiocentesis | No Intervention | Pericardial fluid drained by simple echo-guided pericardiocentesis | |
| Extended pericardial drainage | Active Comparator | Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return<30ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended pericardial drainage by catheter | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent pericardial effusion | 12 months | |
| Need for repeated pericardiocentesis | 12 months | |
| Need for cardiac surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay | 12 months | |
| Disease-related hospitalization | 12 months | |
| Overall mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rates | Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Imazio, MD FESC | Contact | +390114393391 | massimo_imazio@yahoo.it | |
| Riccardo Belli, MD FESC | Contact | +390114393557 |
| Name | Affiliation | Role |
|---|---|---|
| Massimo Imazio, MD | Cardiology Department, Maria Vittoria Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti | Recruiting | Bergamo | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23867908 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months |
| Ospedale Regionale San Maurizio | Active, not recruiting | Bolzano | Italy |
| Ospedale Niguarda | Recruiting | Milan | Italy |
|
| Ospedale degli Infermi | Active, not recruiting | Rivoli | Italy |
| Cardiology Department, Maria Vittoria Hospital | Recruiting | Torino | Italy |
|
| Cardiology Department, Ospedale San Giovanni Bosco | Recruiting | Torino | Italy |
|
| Ospedale Mauriziano | Active, not recruiting | Torino | Italy |
| ID | Term |
|---|---|
| D010490 | Pericardial Effusion |
| D002305 | Cardiac Tamponade |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided