<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/NCT03830645</url>
  </required_header>
  <id_info>
    <org_study_id>ZU-IRB#4931-4-11-2018</org_study_id>
    <nct_id>NCT03830645</nct_id>
  </id_info>
  <brief_title>PRP in 2ry Spontaneous Pneumothorax</brief_title>
  <official_title>Platelet Rich Plasma in Secondary Spontaneous Pneumothorax</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP&#xD;
      with different doses and schedules&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 5, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">November 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Air leak assessment by Cerfolio classification of the air leak by single observer</measure>
    <time_frame>within 10 days after application of platelet rich plasma</time_frame>
    <description>Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay</measure>
    <time_frame>within 10 days after application of platelet rich plasma</time_frame>
    <description>no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung</measure>
    <time_frame>one month after removal of intercostal tube</time_frame>
    <description>no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung</measure>
    <time_frame>two months after removal of intercostal tube</time_frame>
    <description>no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung</measure>
    <time_frame>three months after removal of intercostal tube</time_frame>
    <description>no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung</measure>
    <time_frame>six months after removal of intercostal tube</time_frame>
    <description>no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pneumothorax Spontaneous Secondary</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma</intervention_name>
    <description>Application of platelet rich plasma through the intercostal tube into the pleural space</description>
    <arm_group_label>Platelet rich plasma group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients developed spontanous pneumothorax and was managed with intercostal tube&#xD;
             insertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ahmad Abbas, MD</last_name>
    <phone>201155355369</phone>
    <email>amabbaas@zu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammed Walaa, MD</last_name>
    <phone>201002089696</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Zagazig University Faculty of medicine Chest Department</name>
      <address>
        <city>Zagazig</city>
        <state>Asharqia</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmad Abbas, MD</last_name>
      <phone>201155355369</phone>
      <email>amabbaas@zu.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Ahmad Abbas</investigator_full_name>
    <investigator_title>Principal investigator &amp;lecturer of chest disases zagazig university</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
    <mesh_term>Pneumothorax</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/NCT03830645
org study id: ZU-IRB#4931-4-11-2018
nct id: NCT03830645
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP
      with different doses and schedules
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Air leak assessment by Cerfolio classification of the air leak by single observer
time frame: within 10 days after application of platelet rich plasma
description: Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation
measure: physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
time frame: within 10 days after application of platelet rich plasma
description: no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
time frame: one month after removal of intercostal tube
description: no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
time frame: two months after removal of intercostal tube
description: no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
time frame: three months after removal of intercostal tube
description: no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
measure: recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
time frame: six months after removal of intercostal tube
description: no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
arm group label: Platelet rich plasma group
arm group type: Experimental
intervention type: Biological
intervention name: Platelet Rich Plasma
description: Application of platelet rich plasma through the intercostal tube into the pleural space
arm group label: Platelet rich plasma group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmad Abbas, MD
phone: 201155355369
email: amabbaas@zu.edu.eg
last name: Mohammed Walaa, MD
phone: 201002089696
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Ahmad Abbas
investigator title: Principal investigator &lecturer of chest disases zagazig university
mesh term: Neoplasm Metastasis
mesh term: Pneumothorax