<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/NCT04426487</url>
  </required_header>
  <id_info>
    <org_study_id>625/4-2020</org_study_id>
    <nct_id>NCT04426487</nct_id>
  </id_info>
  <brief_title>Effect of Progesterone Therapy on Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler</brief_title>
  <official_title>Effect of Progesterone Therapy in Cases With Traumatic Subarachinoid Haemorrhage on Clinical Outcome and Resistive Vasculer Indices of Middle Cerebral Artery Transcranial Doppler</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Minia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Minia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic subarachinoid hemorrhage is associated with serious complications related to&#xD;
      mortality . Delayed neuronal ischemia and rebleeding are most common and serious.&#xD;
      Progesterone can delay both .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic&#xD;
      subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic&#xD;
      vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction&#xD;
      through resistive vasculer indices&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 20, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants suffering neuronal infarction</measure>
    <time_frame>2 months</time_frame>
    <description>Transcranial doppler</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receiving conventional management for traumatic subarachinoid hemorrhage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>progesterone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intramusculer progesterone therapy before and after craniotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone</intervention_name>
    <description>Intramusculer progesterone</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>progesterone group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Traumatic subarachinoid hemorrhage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of malignency&#xD;
&#xD;
               -  History of cerebrovasculer stroke&#xD;
&#xD;
               -  Morbid obese&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hany Mikhail, MD</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of medicine. ElMinia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mina Raouf, MD</last_name>
    <phone>01015752424</phone>
    <email>drmina2015@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>ElMinia University</name>
      <address>
        <city>Minya</city>
        <state>Abohelal</state>
        <zip>6115</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hany Mikhail</last_name>
      <phone>01223448665</phone>
      <email>hanykm@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 8, 2020</last_update_submitted>
  <last_update_submitted_qc>June 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ministry of Health and Population, Egypt</investigator_affiliation>
    <investigator_full_name>Mina Maher</investigator_full_name>
    <investigator_title>Principle investigator</investigator_title>
  </responsible_party>
  <keyword>Progesterone</keyword>
  <keyword>Transcranial doppler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04426487
org study id: 625/4-2020
nct id: NCT04426487
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Traumatic subarachinoid hemorrhage is associated with serious complications related to
      mortality . Delayed neuronal ischemia and rebleeding are most common and serious.
      Progesterone can delay both .
Progesterone is an neurosteroid that can help integrity of blood brain barrier . Traumatic
      subarachinoid hemorrhage disrupts this blood brain barrier facilitating post traumatic
      vasospasm and neuronal ischemia. Transcranial doppler can detect cerebral vasoconstriction
      through resistive vasculer indices
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Number of participants suffering neuronal infarction
time frame: 2 months
description: Transcranial doppler
arm group label: Control
arm group type: Placebo Comparator
description: Receiving conventional management for traumatic subarachinoid hemorrhage
arm group label: progesterone group
arm group type: Active Comparator
description: Intramusculer progesterone therapy before and after craniotomy
intervention type: Drug
intervention name: Progesterone
description: Intramusculer progesterone
arm group label: Control
arm group label: progesterone group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hany Mikhail, MD
role: Study Director
affiliation: Faculty of medicine. ElMinia University
last name: Mina Raouf, MD
phone: 01015752424
email: drmina2015@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ministry of Health and Population, Egypt
investigator full name: Mina Maher
investigator title: Principle investigator
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Hemorrhage
mesh term: Progesterone
sharing ipd: No