<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/NCT02974283</url>
  </required_header>
  <id_info>
    <org_study_id>NBO-2016</org_study_id>
    <nct_id>NCT02974283</nct_id>
  </id_info>
  <brief_title>Protective Effects of Normobaric Hyperoxia on Blood Brain Barrier in Patients With Acute Ischemic Stroke</brief_title>
  <official_title>The Effect of Normobaric Hyperoxia on Blood Brain Barrier in AIS Patients Based on a Blood Marker for the Evaluation of Blood Brain Barrier Damage From Animal Experiments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out a serum marker for the evaluation of blood brain&#xD;
      barrier damage based on animal experiments and investigate the effect of NBO（Normobaric&#xD;
      hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA&#xD;
      thrombolytic therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>levels of blood biomarkers</measure>
    <time_frame>7days</time_frame>
    <description>a serum marker for the evaluation of blood brain barrier damage based on animal experiments</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores assessed by National Institutes of Health Stroke Scale(NIHSS)</measure>
    <time_frame>7days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events that are related to treatment</measure>
    <time_frame>7days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Stroke, Acute</condition>
  <arm_group>
    <arm_group_label>NBO group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start within 1 hours after diagnosis of ischemic stroke and last for 4hours. All participants will receive r-tPA thrombolytic therapy and a standard clinical therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normobaric oxygen therapy</intervention_name>
    <description>In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. .&#xD;
Other Names:</description>
    <arm_group_label>NBO group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female with age from 18 to 85;&#xD;
&#xD;
          2. Acute ischemic stroke;&#xD;
&#xD;
          3. National Institutes of Health Stroke Scale (NIHSS) score of 4-25&#xD;
&#xD;
          4. mRS score less than 1 before onset of stroke symptom;&#xD;
&#xD;
          5. Onset of stroke symptoms within 4.5h before initiation of intravenous r-tPA&#xD;
             thrombolytic therapy;&#xD;
&#xD;
          6. Informed consent obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Stroke or serious head trauma within the previous 3 months&#xD;
&#xD;
          2. Major surgery or severe trauma with in the preceding 3 months&#xD;
&#xD;
          3. Intracranial hemorrhage&#xD;
&#xD;
          4. Systolic pressure greater than 185 mm Hg or diastolic pressure greater than 110 mm Hg,&#xD;
             or aggressive treatment intravenous medication) necessary to reduce blood pressure to&#xD;
             these limits&#xD;
&#xD;
          5. Symptoms rapidly improving&#xD;
&#xD;
          6. Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal&#xD;
&#xD;
          7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days&#xD;
&#xD;
          8. Arterial puncture at a noncompressible site within the previous 7 days&#xD;
&#xD;
          9. Seizure at the onset of stroke&#xD;
&#xD;
         10. Platelet count of less than 100,000 per cubic millimeter&#xD;
&#xD;
         11. Received heparin within the 48 hours preceding the onset of stroke and had an elevated&#xD;
             partial-thromboplastin time&#xD;
&#xD;
         12. Received oral anticoagulation therapy preceding the onset of stroke and INR greater&#xD;
             than 1.7 or prothrombin times greater than 15 seconds&#xD;
&#xD;
         13. CT showed a multiple infarction (low density area greater than 1/3 cerebral&#xD;
             hemisphere)&#xD;
&#xD;
         14. severe hepatic or renal dysfunction&#xD;
&#xD;
         15. active and chronic obstructive pulmonary disease or acute respiratory distress&#xD;
             syndrome;&#xD;
&#xD;
         16. &gt;3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2)﹥95%&#xD;
             as per current stroke management guidelines; 17 medically unstable;&#xD;
&#xD;
        18. inability to obtain informed consent. 19. Life expectancy&lt;1 years 20. Pregnant or&#xD;
        breast-feeding women 21. Unwilling to be followed up or poor compliance for treatment 22.&#xD;
        Patients being enrolled or having been enrolled in other clinical trial within 3 months&#xD;
        prior to this clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xunming Ji, MD. Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Capital Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xunming Ji, MD. Ph.D</last_name>
    <phone>+86-10-83198952</phone>
    <email>jixunming@vip.163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuhai Shi, Ph.D.</last_name>
    <phone>+86-13-311145865</phone>
    <email>shishuhai100@126.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Ji Xunming</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Normobaric hyperoxia</keyword>
  <keyword>r-tPA thrombolytic therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Hyperoxia</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/NCT02974283
org study id: NBO-2016
nct id: NCT02974283
lead sponsor: 
has dmc: No
The purpose of this study is to find out a serum marker for the evaluation of blood brain
      barrier damage based on animal experiments and investigate the effect of NBO（Normobaric
      hyperoxia）on blood brain barrier in the acute ischemic stroke patients who received r-tPA
      thrombolytic therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: levels of blood biomarkers
time frame: 7days
description: a serum marker for the evaluation of blood brain barrier damage based on animal experiments
measure: Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
time frame: 7days
measure: Number of participants with adverse events that are related to treatment
time frame: 7days
arm group label: NBO group
arm group type: Experimental
description: Normobaric oxygen therapy is the delivery of high-flow oxygen (10L/min) via oxygen storage facemask. This therapy should start within 1 hours after diagnosis of ischemic stroke and last for 4hours. All participants will receive r-tPA thrombolytic therapy and a standard clinical therapy.
arm group label: Control group
arm group type: No Intervention
description: The participants receive r-tPA thrombolytic therapy after diagnosed ischemic. All participants receive a standard clinical therapy.
intervention type: Other
intervention name: Normobaric oxygen therapy
description: In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. .
Other Names:
arm group label: NBO group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Xunming Ji, MD. Ph.D
role: Principal Investigator
affiliation: Capital Medical University
last name: Xunming Ji, MD. Ph.D
phone: +86-10-83198952
email: jixunming@vip.163.com
last name: Shuhai Shi, Ph.D.
phone: +86-13-311145865
email: shishuhai100@126.com
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Ji Xunming
investigator title: professor
mesh term: Stroke
mesh term: Hyperoxia