<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/NCT02243839</url>
  </required_header>
  <id_info>
    <org_study_id>KOSUYOLU3</org_study_id>
    <nct_id>NCT02243839</nct_id>
  </id_info>
  <brief_title>Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis</brief_title>
  <official_title>Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis: A Randomized Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity&#xD;
      The best treatment of PVT is controversial, although surgery and thrombolysis options have&#xD;
      been available. In this randomized and multicenter study, the investigators compared&#xD;
      thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic&#xD;
      valve thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two different randomization group have been defined and patients with obstructive prosthetic&#xD;
      valve thrombosis are included in each group randomly. In the first arm, thrombolytic therapy&#xD;
      (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT&#xD;
      regimen depends on the functional status of the patient. In patients with NYHA class III-IV&#xD;
      dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients&#xD;
      with NYHA class I-II dyspnea TT with low dose and ultra slow infusion of tPA (25 mg tPA/25&#xD;
      hours) is performed. During TT, patients are followed up with transesophageal&#xD;
      echocardiography in every 24 hours. In the second arm, redo valve surgery is performed for&#xD;
      obstructive valve thrombosis. This multicenter study is conducted in Cardiology and&#xD;
      Cardiovascular Surgery Departments of Kosuyolu Kartal Heart Training and Research Hospital,&#xD;
      Istanbul, Turkey, Siyami Ersek Heart Training and Research Hospital, Istanbul, Turkey, Ankara&#xD;
      Heart Training and Research Hospital, Ankara, Turkey, İzmir Atatürk Heart Training and&#xD;
      Research Hospital, İzmir, Turkey, Erzurum Atatürk University Faculty of Medicine, Erzurum,&#xD;
      Turkey, Diyarbakır Dicle University Faculty of Medicine, Diyarbakır, Turkey and Kars Kafkas&#xD;
      University Faculty of Medicine, Kars, Turkey. Informed consent is taken from all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thrombolytic success</measure>
    <time_frame>Up to 10 days</time_frame>
    <description>In the absence of fatal or nonfatal major complications;&#xD;
Obstructive thrombus:&#xD;
Doppler documentation of the resolution of increased gradient and decreased valve area.&#xD;
Clinical improvement in symptoms. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3&#xD;
Nonobstrucive thrombus:&#xD;
Complete success: ≥75% reduction in thrombus area. Partial success: 50%-75% reduction in thrombus area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-fatal complications for thrombolytic therapy</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
    <description>Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.&#xD;
Nonfatal minor complication: Bleeding without need for transfusion, TIA.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Successful Surgery</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months</time_frame>
    <description>Successful redo valve surgery in the absence of fatal and non fatal major complications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complications for surgery</measure>
    <time_frame>Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month</time_frame>
    <description>Non fatal major complications: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, pericardial tamponade, sepsis, pacemaker requirement, mediastinitis, wound infections, acute renal failure Minor complications: bleeding requiring transfusion, plevral effusion, pericardial effusion without tamponade</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In hospital mortality</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 3 weeks</time_frame>
    <description>All cause in-hospital mortality.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obstructive Thrombus</condition>
  <arm_group>
    <arm_group_label>Thrombolytic therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra-slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thrombolytic Therapy</intervention_name>
    <description>Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis</description>
    <arm_group_label>Thrombolytic therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>Redo valve surgery is performed for obstructive valve thrombosis</description>
    <arm_group_label>Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obstructive prosthetic valve thrombosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-obstructive prosthetic valve thrombosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kosuyolu Kartal Heart Training and Research Hospital</name>
      <address>
        <city>İstanbul</city>
        <zip>34844</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehmet Özkan, Prof</last_name>
      <phone>905322551512</phone>
      <email>memoozkan1@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Mehmet Özkan, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>September 16, 2014</last_update_submitted>
  <last_update_submitted_qc>September 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>MEHMET OZKAN</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prosthetic valve</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Surgery</keyword>
  <keyword>Thrombolytic therapy</keyword>
  <keyword>Transesophageal echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrinolytic Agents</mesh_term>
  </intervention_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/NCT02243839
org study id: KOSUYOLU3
nct id: NCT02243839
lead sponsor: 
has dmc: No
Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity
      The best treatment of PVT is controversial, although surgery and thrombolysis options have
      been available. In this randomized and multicenter study, the investigators compared
      thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic
      valve thrombosis.
Two different randomization group have been defined and patients with obstructive prosthetic
      valve thrombosis are included in each group randomly. In the first arm, thrombolytic therapy
      (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT
      regimen depends on the functional status of the patient. In patients with NYHA class III-IV
      dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients
      with NYHA class I-II dyspnea TT with low dose and ultra slow infusion of tPA (25 mg tPA/25
      hours) is performed. During TT, patients are followed up with transesophageal
      echocardiography in every 24 hours. In the second arm, redo valve surgery is performed for
      obstructive valve thrombosis. This multicenter study is conducted in Cardiology and
      Cardiovascular Surgery Departments of Kosuyolu Kartal Heart Training and Research Hospital,
      Istanbul, Turkey, Siyami Ersek Heart Training and Research Hospital, Istanbul, Turkey, Ankara
      Heart Training and Research Hospital, Ankara, Turkey, İzmir Atatürk Heart Training and
      Research Hospital, İzmir, Turkey, Erzurum Atatürk University Faculty of Medicine, Erzurum,
      Turkey, Diyarbakır Dicle University Faculty of Medicine, Diyarbakır, Turkey and Kars Kafkas
      University Faculty of Medicine, Kars, Turkey. Informed consent is taken from all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Thrombolytic success
time frame: Up to 10 days
description: In the absence of fatal or nonfatal major complications;
Obstructive thrombus:
Doppler documentation of the resolution of increased gradient and decreased valve area.
Clinical improvement in symptoms. Reduction by ≥75% in major diameter or area of the thrombus. Complete success was defined when all 3 criteria were met and partial success was defined as less than 3
Nonobstrucive thrombus:
Complete success: ≥75% reduction in thrombus area. Partial success: 50%-75% reduction in thrombus area
measure: Non-fatal complications for thrombolytic therapy
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
description: Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion.
Nonfatal minor complication: Bleeding without need for transfusion, TIA.
measure: Successful Surgery
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks; and postoperative 3 months
description: Successful redo valve surgery in the absence of fatal and non fatal major complications.
measure: Complications for surgery
time frame: Participants will be followed for the duration of hospital stay an expected average of 3 weeks; and postoperative 3 month
description: Non fatal major complications: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, pericardial tamponade, sepsis, pacemaker requirement, mediastinitis, wound infections, acute renal failure Minor complications: bleeding requiring transfusion, plevral effusion, pericardial effusion without tamponade
measure: In hospital mortality
time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
description: All cause in-hospital mortality.
arm group label: Thrombolytic therapy
arm group type: Active Comparator
description: In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra-slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours.
arm group label: Surgery
arm group type: Active Comparator
description: In the second arm, redo valve surgery is performed for obstructive valve thrombosis. Intraoperative and postoperative results are recorded
intervention type: Drug
intervention name: Thrombolytic Therapy
description: Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis
arm group label: Thrombolytic therapy
intervention type: Procedure
intervention name: Surgery
description: Redo valve surgery is performed for obstructive valve thrombosis
arm group label: Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
investigator full name: MEHMET OZKAN
investigator title: Professor
mesh term: Thrombosis
mesh term: Fibrinolytic Agents