<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/NCT03006120</url>
  </required_header>
  <id_info>
    <org_study_id>2016.5/7-18</org_study_id>
    <nct_id>NCT03006120</nct_id>
  </id_info>
  <brief_title>Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience</brief_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>
  <brief_summary>
    <textblock>
      Bleeding complications after cardiac catheterization have been reviewed previously, but there&#xD;
      are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not&#xD;
      well defined. For this reason, the investigators aimed to analyze the clinical manifestations&#xD;
      of retroperitoneal hematomas in a single center using a case-control study design, to analyze&#xD;
      the treatment procedure determinants and consequently to provide an updated and usable&#xD;
      treatment algorithm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>01/01/2010- 31/10/2016</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Treatment Procedure</condition>
  <condition>Mortality</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Conservative management</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Angiografic stenting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retroperitoneal hematoma due to cardiac catheterization</intervention_name>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Retroperitoneal hematoma following cardiac catheterization in our institution between&#xD;
        January 2010 and October 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retroperitoneal hematoma following cardiac catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with retroperitoneal hematomas other than cardiac catheterization and&#xD;
             patients with missing file records.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 30, 2016</last_update_submitted>
  <last_update_submitted_qc>December 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</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>Ebubekir Gündeş</investigator_full_name>
    <investigator_title>Director,Depertmant of Gastroenterological Surgery, Principal Investigator, Clinical M.D</investigator_title>
  </responsible_party>
  <!-- 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/NCT03006120
org study id: 2016.5/7-18
nct id: NCT03006120
lead sponsor: 
Bleeding complications after cardiac catheterization have been reviewed previously, but there
      are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not
      well defined. For this reason, the investigators aimed to analyze the clinical manifestations
      of retroperitoneal hematomas in a single center using a case-control study design, to analyze
      the treatment procedure determinants and consequently to provide an updated and usable
      treatment algorithm.
observational model: Case-Control
time perspective: Retrospective
measure: Mortality
time frame: 01/01/2010- 31/10/2016
arm group label: Group 1
description: Conservative management
arm group label: Group 2
description: Angiografic stenting
arm group label: Group 3
description: Surgery
intervention type: Procedure
intervention name: Retroperitoneal hematoma due to cardiac catheterization
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
investigator full name: Ebubekir Gündeş
investigator title: Director,Depertmant of Gastroenterological Surgery, Principal Investigator, Clinical M.D