<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/NCT03822260</url>
  </required_header>
  <id_info>
    <org_study_id>TD -001</org_study_id>
    <nct_id>NCT03822260</nct_id>
  </id_info>
  <brief_title>Evaluation of Neuroinflamation of SAH</brief_title>
  <acronym>BAP</acronym>
  <official_title>Comparasion of Bio-markers and Neuroimaging Changes Caused by Neuroenflamation After the Aneurysmal Subarachnoid Hemorrhage</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif 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>
      The investigators are planning that can these markers be used a predictive marker at SAH and&#xD;
      for this aim we will study both patiens' blood sample and their CT image.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An ideal marker which could be used clinically should meet numerous criteria, such as high&#xD;
      sensitivity or the possibility of easy and quick assessment of its concentration in blood or&#xD;
      blood plasma.The Fisher's scale presents an alternative for evaluating patients with&#xD;
      subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and&#xD;
      fishers scale at SAH.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Diagnostic marker identification</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of the concentration levels of enflamation markers relation with Sur1 TRPM+ molecules, together with the values of global tests of coagulation system, may serve as a helpful SAH diagnostic marker.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
  <arm_group>
    <arm_group_label>Sur1/ Trpm 4 acitivities at SAH</arm_group_label>
    <description>only after collecting sample,</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bezmialem VAkif Unv. Ethical board</intervention_name>
    <description>If ıs any trials not convenient to Helsinki Agrement about Human research rules</description>
    <arm_group_label>Sur1/ Trpm 4 acitivities at SAH</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      In the blood plasma stored in the temperature of -86 'C for the period not longer than 6&#xD;
      months, the concentration of the following parameters was marked with the use of&#xD;
      immunoenzymatic ELISA method&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to the emergency room of the universty hospital with aSAH have a CBC&#xD;
        and blood sample performed on admission. Blood samples are obtained significant days&#xD;
        (1,4-14 days) thereafter during their hospitalization.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ruptured Subarachnoid Aneursym&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  without aneursymal sah&#xD;
&#xD;
          -  Patient's positive for rheumatoid factor and anti-CCP or with chronic inflammatory&#xD;
             diseases (such as ankylosing spondylitis or rheumatoid arthritis), systemic diseases&#xD;
             (such as hypercholesterolemia, hypertension, diabetes mellitus, myocardial infarction,&#xD;
             stroke, peripheral artery disease), active infection, a history of term medication,&#xD;
             trauma to the hip and smoking were excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>ıt was not decided</ipd_description>
  </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/NCT03822260
org study id: TD -001
nct id: NCT03822260
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators are planning that can these markers be used a predictive marker at SAH and
      for this aim we will study both patiens' blood sample and their CT image.
An ideal marker which could be used clinically should meet numerous criteria, such as high
      sensitivity or the possibility of easy and quick assessment of its concentration in blood or
      blood plasma.The Fisher's scale presents an alternative for evaluating patients with
      subarachnoid hemorrhage . The investigator are going to evaluate both plasma markers and
      fishers scale at SAH.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic marker identification
time frame: 24 months
description: Evaluation of the concentration levels of enflamation markers relation with Sur1 TRPM+ molecules, together with the values of global tests of coagulation system, may serve as a helpful SAH diagnostic marker.
arm group label: Sur1/ Trpm 4 acitivities at SAH
description: only after collecting sample,
intervention type: Diagnostic Test
intervention name: Bezmialem VAkif Unv. Ethical board
description: If ıs any trials not convenient to Helsinki Agrement about Human research rules
arm group label: Sur1/ Trpm 4 acitivities at SAH
In the blood plasma stored in the temperature of -86 'C for the period not longer than 6
      months, the concentration of the following parameters was marked with the use of
      immunoenzymatic ELISA method
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
sharing ipd: Undecided
ipd description: ıt was not decided