<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665495</url>
  </required_header>
  <id_info>
    <org_study_id>72/16/11</org_study_id>
    <nct_id>NCT01665495</nct_id>
  </id_info>
  <brief_title>Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention</brief_title>
  <acronym>DROP</acronym>
  <official_title>Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maria Vittoria Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maria Vittoria Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The DROP study is a prospective, multi center, randomized, open-label trial to test the&#xD;
      efficacy and safety of extended catheter pericardial drainage in patients with non-malignant&#xD;
      pericardial effusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial will compared the efficacy and safety of pericardiocentesis alone compared with&#xD;
      extended pericardial catheter drainage for the prevention of recurrent effusions in patients&#xD;
      with non-malignant pericardial effusions requiring intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent pericardial effusion</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for repeated pericardiocentesis</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Need for cardiac surgery</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-related hospitalization</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Complication rates</measure>
    <time_frame>12 months</time_frame>
    <description>Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Pericardial Effusion</condition>
  <arm_group>
    <arm_group_label>Pericardiocentesis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pericardial fluid drained by simple echo-guided pericardiocentesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended pericardial drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return&lt;30ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extended pericardial drainage by catheter</intervention_name>
    <description>Extended pericardial drainage will be done after pericardiocentesis by the insertion of a catheter to intermittently drain pericardial fluid till daily fluid return&lt;30 ml.</description>
    <arm_group_label>Extended pericardial drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  pericardial effusion requiring pericardiocentesis&#xD;
&#xD;
          -  non-malignant etiology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known neoplastic etiology&#xD;
&#xD;
          -  known bacterial etiology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo Imazio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cardiology Department, Maria Vittoria Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Massimo Imazio, MD FESC</last_name>
    <phone>+390114393391</phone>
    <email>massimo_imazio@yahoo.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Riccardo Belli, MD FESC</last_name>
    <phone>+390114393557</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ospedali Riuniti</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Brucato, MD</last_name>
    </contact>
    <investigator>
      <last_name>Antonio Brucato, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Regionale San Maurizio</name>
      <address>
        <city>Bolzano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Gandino, MD</last_name>
    </contact>
    <investigator>
      <last_name>Anna Gandino, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi</name>
      <address>
        <city>Rivoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cardiology Department, Maria Vittoria Hospital</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Imazio, MD,FESC</last_name>
      <phone>+39 0114393391</phone>
    </contact>
    <investigator>
      <last_name>Massimo Imazio, MD FESC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Riccardo Belli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Massimo Giammaria, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Federico Beqeraj, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiology Department, Ospedale San Giovanni Bosco</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Massimo Minelli, MD</last_name>
    </contact>
    <investigator>
      <last_name>Massimo Minelli, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Mauriziano</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maria Vittoria Hospital</investigator_affiliation>
    <investigator_full_name>Massimo Imazio</investigator_full_name>
    <investigator_title>Cardiologist</investigator_title>
  </responsible_party>
  <keyword>pericardial effusion</keyword>
  <keyword>cardiac tamponade</keyword>
  <keyword>pericardiocentesis</keyword>
  <keyword>pericardial drainage</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pericardial Effusion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665495
org study id: 72/16/11
nct id: NCT01665495
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Recurrent pericardial effusion
time frame: 12 months
measure: Need for repeated pericardiocentesis
time frame: 12 months
measure: Need for cardiac surgery
time frame: 12 months
measure: Hospital stay
time frame: 12 months
measure: Disease-related hospitalization
time frame: 12 months
measure: Overall mortality
time frame: 12 months
measure: Complication rates
time frame: 12 months
description: Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up
arm group label: Pericardiocentesis
arm group type: No Intervention
description: Pericardial fluid drained by simple echo-guided pericardiocentesis
arm group label: Extended pericardial drainage
arm group type: Active Comparator
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: Extended pericardial drainage by catheter
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.
arm group label: Extended pericardial drainage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Massimo Imazio, MD
role: Principal Investigator
affiliation: Cardiology Department, Maria Vittoria Hospital
last name: Massimo Imazio, MD FESC
phone: +390114393391
email: massimo_imazio@yahoo.it
last name: Riccardo Belli, MD FESC
phone: +390114393557
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Maria Vittoria Hospital
investigator full name: Massimo Imazio
investigator title: Cardiologist
mesh term: Pericardial Effusion