<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/NCT03244436</url>
  </required_header>
  <id_info>
    <org_study_id>Surgery after catheterization</org_study_id>
    <nct_id>NCT03244436</nct_id>
  </id_info>
  <brief_title>Emergency Surgery Following Pediatric Catheterization</brief_title>
  <official_title>Emergency Surgery Following Pediatric Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We study the outcome and prequesties of emergency surgeries that were necessary following&#xD;
      accidents in the pediatric cardiac catheterization lab&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2013</start_date>
  <completion_date type="Actual">June 15, 2015</completion_date>
  <primary_completion_date type="Actual">June 15, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Discharge from ICU</measure>
    <time_frame>A 2 years study</time_frame>
  </primary_outcome>
  <enrollment type="Actual">190</enrollment>
  <condition>Anesthesia</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery following catheterization</intervention_name>
    <description>Emergency surgery following pediatric cardiac catheterization</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        190 pediatric patients presenting for either diagnostic or interventional cardiac&#xD;
        catheterization&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients presenting for diagnostic or therapeutic pediatric cardiac catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Kareem</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03244436
org study id: Surgery after catheterization
nct id: NCT03244436
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
We study the outcome and prequesties of emergency surgeries that were necessary following
      accidents in the pediatric cardiac catheterization lab
observational model: Other
time perspective: Retrospective
measure: Discharge from ICU
time frame: A 2 years study
intervention type: Procedure
intervention name: Surgery following catheterization
description: Emergency surgery following pediatric cardiac catheterization
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 2 Months
maximum age: 9 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Kareem
investigator title: Dr.
mesh term: Emergencies
sharing ipd: Undecided