Pericardial EffusionDROPNCT01665495
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
A study testing Extended pericardial drainage by catheter in people with Pericardial Effusion, run by Maria Vittoria Hospital at 7 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pericardial Effusion
- What is being tested?
- Extended pericardial drainage by catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesItaly
- Study dates
- Dec 2011to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- pericardial effusion requiring pericardiocentesis
- non-malignant etiology
Who cannot join
- known neoplastic etiology
- known bacterial etiology
Trial locations and contacts
7 sites in 1 country.
Riccardo Belli, MD FESC contact
7 sites in 1 country
Italy7 sites, 4 recruiting
- Recruiting
Ospedali Riuniti
Bergamo
Antonio Brucato, MD
Antonio Brucato, MD
- Active, not recruiting
Ospedale Regionale San Maurizio
Bolzano
- Recruiting
Ospedale Niguarda
Milan
Anna Gandino, MD
Anna Gandino, MD
- Active, not recruiting
Ospedale degli Infermi
Rivoli
- Recruiting
Cardiology Department, Maria Vittoria Hospital
Torino
Massimo Imazio, MD,FESC, +39 0114393391
Massimo Imazio, MD FESC
- Recruiting
Cardiology Department, Ospedale San Giovanni Bosco
Torino
Massimo Minelli, MD
Massimo Minelli, MD
- Active, not recruiting
Ospedale Mauriziano
Torino
About this study
Official title: Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
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.
Read the 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.
- Conditions
- Pericardial Effusion
- Being tested
- Extended pericardial drainage by catheter
- Keywords
- pericardial effusion, cardiac tamponade, pericardiocentesis, pericardial drainage, prevention
- Medical subject headings
- Pericardial Effusion, Cardiac Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended pericardial drainage by catheterProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Extended pericardial drainage by catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent pericardial effusion
Measured: 12 months
Need for repeated pericardiocentesis
Measured: 12 months
Need for cardiac surgery
Measured: 12 months
Secondary outcomes (3)
Hospital stay
Measured: 12 months
Disease-related hospitalization
Measured: 12 months
Overall mortality
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pericardial EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Vittoria Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Imazio, Maria Vittoria Hospital
- Investigators
- Massimo Imazio, MD, Principal investigator, Cardiology Department, Maria Vittoria Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665495
- Sponsor's protocol ID
- 72/16/11
- Acronym
- DROP
- Status last verified
- Aug 2012
- First submitted
- 12 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23867908
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
- ClinicalTrials.gov ID
- NCT01665495
- Acronym / sponsor ID
- DROP / 72/16/11
- Conditions
- Pericardial Effusion
- Keywords
- pericardial effusion, cardiac tamponade, pericardiocentesis, pericardial drainage, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Maria Vittoria HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericardiocentesis | No intervention | –Pericardial fluid drained by simple echo-guided pericardiocentesis |
| Extended pericardial drainage | Active comparator | Procedure: Extended pericardial drainage by catheterExtended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return<30ml |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients
- pericardial effusion requiring pericardiocentesis
- non-malignant etiology
Key exclusion criteria (2 listed)
- known neoplastic etiology
- known bacterial etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended pericardial drainage by catheterExtended pericardial drainage will be done after pericardiocentesis by the insertion of a catheter to intermittently drain pericardial fluid till daily fluid return<30 ml. | Procedure or surgery | Extended pericardial drainage |
Primary outcome
Recurrent pericardial effusion
Time frame: 12 months
Need for repeated pericardiocentesis
Time frame: 12 months
Need for cardiac surgery
Time frame: 12 months
3 secondary outcomes
Hospital stay
Time frame: 12 months
Disease-related hospitalization
Time frame: 12 months
Overall mortality
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
- Derived from this study: PubMed 23867908Imazio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riccardo Belli, MD FESC contact
Massimo Imazio, MD principal investigator
Cardiology Department, Maria Vittoria Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended pericardial drainage by catheter in people with Pericardial Effusion, run by Maria Vittoria Hospital at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Imazio, MD FESC (+390114393391, massimo_imazio@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent pericardial effusion (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2012.