xml: <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/NCT06009016</url>
    </required_header>
    <id_info>
      <org_study_id>2023-059</org_study_id>
      <nct_id>NCT06009016</nct_id>
    </id_info>
    <brief_title>Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH</brief_title>
    <official_title>Inflammation and Coagulation Factors in Cerebrospinal Fluid for Predicting Persistent Cerebral Edema After Subarachnoid Hemorrhage</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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>
        Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for&#xD;
        predicting persistent cerebral edema after subarachnoid hemorrhage&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>Cerebral edema after subarachnoid hemorrhage</measure>
      <time_frame>At 3 and 7days after SAH onset</time_frame>
      <description>Cerebral edema after subarachnoid hemorrhage will be determined by the SEBES score. SEBES 0-2 is mild edema; SEBES 3-4 is severe edema.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Outcome at 3 months after subarachnoid hemorrhage</measure>
      <time_frame>3 months after subarachnoid hemorrhage</time_frame>
      <description>Outcome will be determined by the modified Rankin Score (mRS). mRS 0-2 is favorable outcome; mRS3-5 is poor outcome.</description>
    </primary_outcome>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Inflammation</condition>
    <condition>Coagulation and Hemorrhagic Disorders</condition>
    <condition>Cerebral Edema</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Inflammatory factors and coagulation factors level in cerebrospinal fluid after subarachnoid hemorrhage</intervention_name>
      <description>Inflammatory factors and coagulation factors level in cerebrospinal fluid will be tested by ELISA kits.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified&#xD;
          Fisher Scale 3-4, with a confirmed radiographic diagnosis. Age range from 20-80.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subarachnoid hemorrhage patients admitted to our neurosurgery department with modified&#xD;
               Fisher Scale 3-4, with a confirmed radiographic diagnosis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Angiogram-negative patients, patients with a history of trauma or previous brain&#xD;
               injury (stroke, hemorrhage, surgery et al. which left associated chronic changes on&#xD;
               CT), arteriovenous malformation, radiological data lost, accompany with serious&#xD;
               comorbidities before subarachnoid hemorrhage onset (such as coagulation defects,&#xD;
               uncontrollable hypertension, and arrhythmia et.al.), initial radiological data&#xD;
               performed more than 3 days after SAH onset&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yuanjian Fang, M.D</last_name>
      <phone>86-18768109541</phone>
      <email>sandman0506@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sheng Chen, M.D</last_name>
      <phone>86-13645814323</phone>
      <email>saintchan@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Second affiliated hospital of Zhejiang University, School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuanjian Fang, M.D</last_name>
        <phone>86-18768109541</phone>
        <email>sandman0506@foxmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
      <investigator_full_name>Yuanjian Fang</investigator_full_name>
      <investigator_title>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Edema</mesh_term>
      <mesh_term>Hemorrhagic Disorders</mesh_term>
      <mesh_term>Inflammation</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009016
  org study id: 2023-059
  nct id: NCT06009016
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for
        predicting persistent cerebral edema after subarachnoid hemorrhage
  observational model: Cohort
  time perspective: Prospective
  measure: Cerebral edema after subarachnoid hemorrhage
  time frame: At 3 and 7days after SAH onset
  description: Cerebral edema after subarachnoid hemorrhage will be determined by the SEBES score. SEBES 0-2 is mild edema; SEBES 3-4 is severe edema.
  measure: Outcome at 3 months after subarachnoid hemorrhage
  time frame: 3 months after subarachnoid hemorrhage
  description: Outcome will be determined by the modified Rankin Score (mRS). mRS 0-2 is favorable outcome; mRS3-5 is poor outcome.
  intervention type: Diagnostic Test
  intervention name: Inflammatory factors and coagulation factors level in cerebrospinal fluid after subarachnoid hemorrhage
  description: Inflammatory factors and coagulation factors level in cerebrospinal fluid will be tested by ELISA kits.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Yuanjian Fang, M.D
  phone: 86-18768109541
  email: sandman0506@zju.edu.cn
  last name: Sheng Chen, M.D
  phone: 86-13645814323
  email: saintchan@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
  investigator full name: Yuanjian Fang
  investigator title: Second Affiliated Hospital, School of Medicine, Zhejiang University
  mesh term: Brain Edema
  mesh term: Hemorrhagic Disorders
  mesh term: Inflammation
  mesh term: Edema
  sharing ipd: Undecided