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/NCT05965687</url>
    </required_header>
    <id_info>
      <org_study_id>OPENS-3</org_study_id>
      <nct_id>NCT05965687</nct_id>
    </id_info>
    <brief_title>Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)</brief_title>
    <official_title>Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ji Xunming,MD,PhD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Shijitan Hospital, Capital Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Tongren Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>People's Hospital of Beijing Daxing District</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin Huanhu Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guizhou Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong Provincial Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Zhengzhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Hospital of Xuzhou Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong Jining No.1 People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Linyi People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nanyang Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rizhao People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zhumadian Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Affiliated Hospital of Nanchang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Affiliated Hospital of Nantong University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Second Hospital of Anhui Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Changsha Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jiujiang University Affiliated Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liaocheng People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Chengde Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Anhui Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Jiangxi Provincial People's Hopital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Capital Medical 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>
        The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia&#xD;
        combined with intravenous thrombolysis for acute ischemic stroke.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5&#xD;
        hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous&#xD;
        thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a&#xD;
        sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control&#xD;
        group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation&#xD;
        rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators&#xD;
        aimed to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous&#xD;
        thrombolysis for acute ischemic stroke.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 17, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>Phase 3</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Excellent functional outcome</measure>
      <time_frame>90±7 days after randomization</time_frame>
      <description>Proportion of subjects with modified Rankin Scale(mRS) 0-1 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cerebral infarct volume</measure>
      <time_frame>24-48hours after randomization</time_frame>
      <description>The infarct volume of cerebral infarct is evaluated by MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>modified rankin scale (mRS) score</measure>
      <time_frame>90±7 days after randomization</time_frame>
      <description>Ordinal distribution of mRS at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Good functional outcome</measure>
      <time_frame>90 ± 7 days after randomization</time_frame>
      <description>Proportion of subjects with modified rankin scale (mRS) 0-2 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with modified rankin scale (mRS) 0-3</measure>
      <time_frame>90 ± 7 days after randomization</time_frame>
      <description>Proportion of subjects with mRS 0-3 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scores assessed by National Institutes of Health Stroke Scale(NIHSS)</measure>
      <time_frame>4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization</time_frame>
      <description>Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of neurological function improvement</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>≥ 4 point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 6 hours after randomization;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of subjects with modified rankin scale (mRS) 0-1</measure>
      <time_frame>30 ± 7 days after randomization</time_frame>
      <description>Proportion of subjects with mRS 0-1 at 30±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barthel Index (BI)</measure>
      <time_frame>30 ± 7 days,90 ± 7 days after randomization</time_frame>
      <description>The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EuroQol five dimensions questionnaire（EQ-5D）</measure>
      <time_frame>30 ± 7 days,90 ± 7 days after randomization</time_frame>
      <description>The score ranges from 0 to 100, with higher scores indicating optimal health</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days of hospitalization</measure>
      <time_frame>30 ± 7 days after randomization</time_frame>
      <description>Length of stay in hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroke-related mortality</measure>
      <time_frame>90 ± 7 days after randomization</time_frame>
      <description>Safety endpoint; the proportion of stroke related deaths in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>90 ± 7 days after randomization</time_frame>
      <description>Safety endpoint; the proportion of all patients who died in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptomatic intracranial hemorrhage</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asymptomatic intracranial hemorrhage</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PH2 intracranial hemorrhage</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Any intracranial hemorrhage</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>The incidence of any intracranial hemorrhage at 24 ± 6 hours after randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systematic bleeding</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>The incidence of systematic bleeding at 24 ± 6 hours after randomization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early neurological deterioration</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Safety endpoint; defined as ≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score from baseline;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygen-related adverse events</measure>
      <time_frame>90 ± 7 days after randomization</time_frame>
      <description>Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events/serious adverse events</measure>
      <time_frame>24 ± 12 hours, 7 ± 2 days, 90± 7 days after randomization</time_frame>
      <description>Safety endpoint; the proportion of adverse events/serious adverse events in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PaO2 of arterial blood gas analysis</measure>
      <time_frame>after 4 hours of oxygen therapy</time_frame>
      <description>Safety endpoint</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PaCO2 of arterial blood gas analysis</measure>
      <time_frame>after 4 hours of oxygen therapy</time_frame>
      <description>Safety endpoint</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Potential of hydrogen(PH) of arterial blood gas analysis</measure>
      <time_frame>after 4 hours of oxygen therapy</time_frame>
      <description>Safety endpoint</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of Lactic acid of arterial blood gas analysis</measure>
      <time_frame>after 4 hours of oxygen therapy</time_frame>
      <description>Safety endpoint</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic and diastolic blood pressure</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Safety endpoint; vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Safety endpoint; vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Safety endpoint; vital signs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygen saturation</measure>
      <time_frame>24 ± 6 hours after randomization</time_frame>
      <description>Safety endpoint; vital signs</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1102</enrollment>
    <condition>Acute Ischemic Stroke</condition>
    <arm_group>
      <arm_group_label>NBO group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Normobaric Hyperoxia combined with intravenous thrombolysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Nasal oxygen combined with intravenous thrombolysis</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Normobaric Hyperoxia</intervention_name>
      <description>Within 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.</description>
      <arm_group_label>NBO group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Nasal oxygen</intervention_name>
      <description>For nasal oxygen group, patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Intravenous thrombolysis(rt-PA)</intervention_name>
      <description>10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>NBO group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age≥18 years;&#xD;
  &#xD;
            2. The time from onset to randomization is within 4.5 hours of onset;&#xD;
  &#xD;
            3. The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese&#xD;
               Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018);&#xD;
  &#xD;
            4. Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points;&#xD;
  &#xD;
            5. Pre-stroke mRS score≤1 points;&#xD;
  &#xD;
            6. Informed consent from the patient or surrogate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular&#xD;
               hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.);&#xD;
  &#xD;
            2. Past history of intracranial hemorrhage;&#xD;
  &#xD;
            3. Rapid neurological function improvement, NIHSS score less than 5 points;&#xD;
  &#xD;
            4. Presence of proximal arterial occlusion on computed tomographic&#xD;
               angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal&#xD;
               carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries);&#xD;
  &#xD;
            5. Massive anterior cerebral infarction identified by CT or MRI (ASPECT &lt; 6 or lesions&#xD;
               larger than one third of the territory of the middle cerebral artery);&#xD;
  &#xD;
            6. Intended to proceed endovascular treatment;&#xD;
  &#xD;
            7. Pregnant women, or planning to become pregnant during the trial;&#xD;
  &#xD;
            8. A history of severe head trauma or stroke within 3 months;&#xD;
  &#xD;
            9. A history of intracranial or spinal surgery within 3 months;&#xD;
  &#xD;
           10. A history of gastrointestinal or urinary bleeding within 3 weeks;&#xD;
  &#xD;
           11. two weeks of major surgery;&#xD;
  &#xD;
           12. Arterial puncture was performed at the hemostasis site that was not easily compressed&#xD;
               within 1 week;&#xD;
  &#xD;
           13. Active visceral bleeding;&#xD;
  &#xD;
           14. Intracranial tumors, large intracranial aneurysms;&#xD;
  &#xD;
           15. Aortic arch dissection was found;&#xD;
  &#xD;
           16. Severe, sustained hypertension (Systolic Blood Pressure &gt;185 mmHg or Diastolic Blood&#xD;
               Pressure &gt;110 mmHg);&#xD;
  &#xD;
           17. Baseline blood glucose of &lt;50mg/dL (2.78 mmol) or &gt;400mg/dL (22.20 mmol);&#xD;
  &#xD;
           18. Oral warfarin anticoagulant with international normalized ratio(INR)&gt;1.7 or&#xD;
               prothrombin time(PT)&gt;15 s;&#xD;
  &#xD;
           19. Heparin treatment was received within 24 h;&#xD;
  &#xD;
           20. Thrombin inhibitors or factor Xa inhibitors were used within 48 h;&#xD;
  &#xD;
           21. Propensity for acute bleeding, including platelet counts of less than 100×109/ L or&#xD;
               otherwise;&#xD;
  &#xD;
           22. Hereditary or acquired bleeding constitution;&#xD;
  &#xD;
           23. Onset with seizures;&#xD;
  &#xD;
           24. Severe liver and kidney dysfunction;&#xD;
  &#xD;
           25. Active and chronic obstructive pulmonary disease or acute respiratory distress&#xD;
               syndrome;&#xD;
  &#xD;
           26. Patients with anemia or polycythemia vera or other situations that require urgent&#xD;
               oxygen inhalation;&#xD;
  &#xD;
           27. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they&#xD;
               cannot cooperate with the mask to inhale oxygen;&#xD;
  &#xD;
           28. Life expectancy &lt; 1 year;&#xD;
  &#xD;
           29. Patients who could not complete the 90-day follow-up;&#xD;
  &#xD;
           30. Participation in other clinical trials within 3 months prior to screening;&#xD;
  &#xD;
           31. Unsuitability or participation in this study as judged by the Investigator may result&#xD;
               in subjects being exposed to greater risk.&#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>Xunming Ji, MD. PhD</last_name>
      <phone>+86010-83199430</phone>
      <email>jixm@ccmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hetao Bian, MD.PhD</last_name>
      <phone>+8618266806812</phone>
      <email>hetaobian@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Xuan Wu Hospital，Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xunming Ji, MD. PhD</last_name>
        <phone>861013120136877</phone>
        <email>jixunming@vip.163.com</email>
      </contact>
      <investigator>
        <last_name>Xunming Ji, MD. PhD Xuanwu Hospital</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Capital Medical University</investigator_affiliation>
      <investigator_full_name>Ji Xunming,MD,PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Cerebral Infarction</mesh_term>
      <mesh_term>Ischemia</mesh_term>
      <mesh_term>Hyperoxia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT05965687
  org study id: OPENS-3
  nct id: NCT05965687
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  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine the efficacy and safety of Normobaric Hyperoxia
        combined with intravenous thrombolysis for acute ischemic stroke.
  In this study, cases of acute ischemic stroke who undergo intravenous thrombolysis within 4.5
        hours from onset are included. The Normobaric Hyperoxia(NBO) group receive basic intravenous
        thrombolysis and given 100% oxygen inhalation at a ventilation rate of 10L/ min using a
        sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. The control
        group receive basic intravenous thrombolysis and given oxygen inhalation at a ventilation
        rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. The investigators
        aimed to determine the efficacy and safety of Normobaric Hyperoxia combined with intravenous
        thrombolysis for acute ischemic stroke.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Excellent functional outcome
  time frame: 90±7 days after randomization
  description: Proportion of subjects with modified Rankin Scale(mRS) 0-1 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
  measure: Cerebral infarct volume
  time frame: 24-48hours after randomization
  description: The infarct volume of cerebral infarct is evaluated by MRI
  measure: modified rankin scale (mRS) score
  time frame: 90±7 days after randomization
  description: Ordinal distribution of mRS at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
  measure: Good functional outcome
  time frame: 90 ± 7 days after randomization
  description: Proportion of subjects with modified rankin scale (mRS) 0-2 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
  measure: Proportion of subjects with modified rankin scale (mRS) 0-3
  time frame: 90 ± 7 days after randomization
  description: Proportion of subjects with mRS 0-3 at 90±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
  measure: Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
  time frame: 4 ± 2 hours, 24 ± 6 hours, 72 ± 24 hours, 7 ± 2 days after randomization
  description: Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficits
  measure: The proportion of neurological function improvement
  time frame: 24 ± 6 hours after randomization
  description: ≥ 4 point reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline at 24 ± 6 hours after randomization;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome
  measure: Proportion of subjects with modified rankin scale (mRS) 0-1
  time frame: 30 ± 7 days after randomization
  description: Proportion of subjects with mRS 0-1 at 30±7 days after randomization;mRS score ranges from 0 to 5, and the higher score means a worse outcome
  measure: Barthel Index (BI)
  time frame: 30 ± 7 days,90 ± 7 days after randomization
  description: The BI is an ordinal disability score of 10 categories (range from 0 to 100, higher values indicate better prognosis)
  measure: EuroQol five dimensions questionnaire（EQ-5D）
  time frame: 30 ± 7 days,90 ± 7 days after randomization
  description: The score ranges from 0 to 100, with higher scores indicating optimal health
  measure: Days of hospitalization
  time frame: 30 ± 7 days after randomization
  description: Length of stay in hospital
  measure: Stroke-related mortality
  time frame: 90 ± 7 days after randomization
  description: Safety endpoint; the proportion of stroke related deaths in each group
  measure: All-cause mortality
  time frame: 90 ± 7 days after randomization
  description: Safety endpoint; the proportion of all patients who died in each group
  measure: Symptomatic intracranial hemorrhage
  time frame: 24 ± 6 hours after randomization
  description: Proportion of subjects with symptomatic intracranial hemorrhage at 24 ± 6 hours after randomization (defined by ECASSII and ECASS III)
  measure: Asymptomatic intracranial hemorrhage
  time frame: 24 ± 6 hours after randomization
  description: The incidence of asymptomatic intracranial hemorrhage at 24 ± 6 hours after randomization
  measure: PH2 intracranial hemorrhage
  time frame: 24 ± 6 hours after randomization
  description: The incidence of PH2 intracranial hemorrhage at 24 ± 6 hours after randomization (according to SITS standards)
  measure: Any intracranial hemorrhage
  time frame: 24 ± 6 hours after randomization
  description: The incidence of any intracranial hemorrhage at 24 ± 6 hours after randomization
  measure: Systematic bleeding
  time frame: 24 ± 6 hours after randomization
  description: The incidence of systematic bleeding at 24 ± 6 hours after randomization
  measure: Early neurological deterioration
  time frame: 24 ± 6 hours after randomization
  description: Safety endpoint; defined as ≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score from baseline;NIHSS score ranges from 0 to 42, and higher scores mean a worse outcome
  measure: Oxygen-related adverse events
  time frame: 90 ± 7 days after randomization
  description: Safety endpoint; the proportion of oxygen-related adverse events in each group, including severe lung infection, pneumothorax, atelectasis, respiratory failure, acute respiratory distress syndrome, and cardiopulmonary arrest
  measure: Adverse events/serious adverse events
  time frame: 24 ± 12 hours, 7 ± 2 days, 90± 7 days after randomization
  description: Safety endpoint; the proportion of adverse events/serious adverse events in each group
  measure: PaO2 of arterial blood gas analysis
  time frame: after 4 hours of oxygen therapy
  description: Safety endpoint
  measure: PaCO2 of arterial blood gas analysis
  time frame: after 4 hours of oxygen therapy
  description: Safety endpoint
  measure: Potential of hydrogen(PH) of arterial blood gas analysis
  time frame: after 4 hours of oxygen therapy
  description: Safety endpoint
  measure: Concentration of Lactic acid of arterial blood gas analysis
  time frame: after 4 hours of oxygen therapy
  description: Safety endpoint
  measure: Systolic and diastolic blood pressure
  time frame: 24 ± 6 hours after randomization
  description: Safety endpoint; vital signs
  measure: Heart rate
  time frame: 24 ± 6 hours after randomization
  description: Safety endpoint; vital signs
  measure: Respiratory rate
  time frame: 24 ± 6 hours after randomization
  description: Safety endpoint; vital signs
  measure: Oxygen saturation
  time frame: 24 ± 6 hours after randomization
  description: Safety endpoint; vital signs
  arm group label: NBO group
  arm group type: Experimental
  description: Normobaric Hyperoxia combined with intravenous thrombolysis
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Nasal oxygen combined with intravenous thrombolysis
  intervention type: Procedure
  intervention name: Normobaric Hyperoxia
  description: Within 4.5 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
  arm group label: NBO group
  intervention type: Procedure
  intervention name: Nasal oxygen
  description: For nasal oxygen group, patients were immediately given oxygen inhalation (no more than 30 minutes after randomization) at a ventilation rate of 1L/min using nasal cannula and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%.
  arm group label: Control group
  intervention type: Drug
  intervention name: Intravenous thrombolysis(rt-PA)
  description: 10% dose of rt-PA (0.9 mg/kg) is given as bolus and the rest given as an infusion over the remaining 1 hour. Maximum dose 90mg.
  arm group label: Control group
  arm group label: NBO group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xunming Ji, MD. PhD
  phone: +86010-83199430
  email: jixm@ccmu.edu.cn
  last name: Hetao Bian, MD.PhD
  phone: +8618266806812
  email: hetaobian@163.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Capital Medical University
  investigator full name: Ji Xunming,MD,PhD
  investigator title: Professor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Cerebral Infarction
  mesh term: Ischemia
  mesh term: Hyperoxia
  sharing ipd: No