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/NCT05993078</url>
    </required_header>
    <id_info>
      <org_study_id>NS-STAR-1</org_study_id>
      <nct_id>NCT05993078</nct_id>
    </id_info>
    <brief_title>Normal Saline Infusion for Stroke After Intravenous Thrombolysis</brief_title>
    <acronym>NS-STAR</acronym>
    <official_title>Safety and Efficacy of Immediate Normal Saline Infusion for Stroke After Intravenous Thrombolysis (NS-STAR): a Protocol of Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University General Hospital</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>
        This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on&#xD;
        stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre&#xD;
        randomized controlled trial for the first time. This trial will provide an innovative&#xD;
        strategy to facilitate functional independence after stroke administered with IVT. This is a&#xD;
        multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled&#xD;
        participators will be divided into NS group and control group randomly after confirming as&#xD;
        acute ischemic stroke (AIS) according to symptoms and signs. In NS group, the patient will&#xD;
        undergo NS 2000ml intravenous infusion swiftly after IVT, with the speed of 200ml/h. In&#xD;
        control group, the patient will not undergo NS intravenous infusion after IVT. The primary&#xD;
        efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS),&#xD;
        dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score&#xD;
        of 2 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging&#xD;
        and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema&#xD;
        at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the&#xD;
        cardiac function detected by ultrasonic cardiogram within 3 days after IVT. Stata 15.1 and R&#xD;
        software will be used for statistical analysis&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>90-day favorable outcome</measure>
      <time_frame>90 days</time_frame>
      <description>Disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score of 2 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>NIHSS scores at 24 hours</measure>
      <time_frame>24 hours</time_frame>
      <description>The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (&lt;5, mild impairment; ≥25, very severe neurologic impairment).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NIHSS scores at days 7</measure>
      <time_frame>7 days</time_frame>
      <description>The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (&lt;5, mild impairment; ≥25, very severe neurologic impairment).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mRS at days 7</measure>
      <time_frame>7 days</time_frame>
      <description>Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mRS at days 30</measure>
      <time_frame>30 days</time_frame>
      <description>Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>volume of infarction at 24 hours</measure>
      <time_frame>24 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>early neurological deterioration</measure>
      <time_frame>24 hours</time_frame>
      <description>Early neurological deterioration indicates an increase of 4 or more points on the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Brain Infarct</condition>
    <arm_group>
      <arm_group_label>NS group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The patient will not undergo 0.9% NaCl intravenous infusion after IVT.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.9% NaCl 2000ml</intervention_name>
      <description>The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.</description>
      <arm_group_label>NS group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.9% NaCl 0ml</intervention_name>
      <description>The patient will not undergo 0.9% NaCl intravenous infusion after IVT.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria：&#xD;
  &#xD;
            -  Acute ischemic stroke (AIS)&#xD;
  &#xD;
            -  Age 18-80 years&#xD;
  &#xD;
            -  Pre-stroke mRS≤1&#xD;
  &#xD;
            -  Onset-to-needle time≤4.5 hours&#xD;
  &#xD;
            -  Treated with alteplase&#xD;
  &#xD;
            -  Initial diagnosis of penetrating artery disease, large artery atherosclerosis (LAA)&#xD;
               inducing parent artery (plaque or thrombus) occluding penetrating artery and LAA&#xD;
               inducing hypoperfusion defined by Chinese ischemic stroke subclassification (CISS)&#xD;
               system&#xD;
  &#xD;
            -  Sign the informed consent&#xD;
  &#xD;
          Exclusion Criteria：&#xD;
  &#xD;
            -  Severe AIS, including NIHSS score&gt;20 in dominant hemisphere infarction, or NIHSS&#xD;
               score&gt;15 in non-dominant hemisphere infarction, or NIHSS consciousness score &gt;1&#xD;
  &#xD;
            -  Massive infarction, characterized by infarction area larger than 1/3 of the effected&#xD;
               middle cerebral artery (MCA) territory and/or the cerebellum territory presented in&#xD;
               admitted CT or MRI&#xD;
  &#xD;
            -  Initial diagnosis of LAA inducing artery-to-artery embolism, cardiogenic stroke, other&#xD;
               etiologies and undetermined etiologies defined by CISS system&#xD;
  &#xD;
            -  Intention to undergo endovascular treatment&#xD;
  &#xD;
            -  Intention to undergo antiplatelet drugs within 24 hours after IVT, such as aspirin,&#xD;
               clopidogrel, ticagrelor, cilostazol and tirofiban&#xD;
  &#xD;
            -  Allergy to alteplase&#xD;
  &#xD;
            -  Arterial puncture at a non-compressible site within previous 7 days, major surgery&#xD;
               within previous 14 days, sever trauma, gastrointestinal or urinary tract bleeding&#xD;
               within previous 21 days&#xD;
  &#xD;
            -  Cerebral infarction or myocardial infarction within previous 3 months, previous&#xD;
               intracranial haemorrhage (ICH) including parenchymal haemorrhage, intraventricular&#xD;
               haemorrhage, subarachnoid haemorrhage, subdural/external haematoma, etc&#xD;
  &#xD;
            -  Severe brain trauma, intracranial or intraspinal surgery within previous 3 months or&#xD;
               known malignant intracranial neoplasm, giant intracranial aneurysm or arteriovenous&#xD;
               malformation&#xD;
  &#xD;
            -  Persistent systolic blood pressure≥180mmHg or diastolic blood pressure≥100mmHg&#xD;
  &#xD;
            -  Admitted blood glucose&lt;2.8mmol/L or &gt;22.22mmol/L&#xD;
  &#xD;
            -  Defect in coagulation, for example, current use of oral warfarin with an international&#xD;
               normalised ratio&gt;1.7, or prothrombin time&gt;15s, or heparins during the last 48 hours,&#xD;
               or use of direct thrombin inhibitors or direct factor Xa inhibitors during the last 48&#xD;
               hours or with an elevated activated partial thromboplastin time&#xD;
  &#xD;
            -  Platelet count&lt;100×109/L&#xD;
  &#xD;
            -  Stroke mimics, such as seizure and hysteria&#xD;
  &#xD;
            -  Brain haemorrhage identified by CT or MRI&#xD;
  &#xD;
            -  Any terminal illness such that patients would not be expected to survive&gt;1 year&#xD;
  &#xD;
            -  Pregnant women or nursing mother&#xD;
  &#xD;
            -  Poor compliance&#xD;
  &#xD;
            -  Participating in other clinical trials within previous 3 months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tianjin Medical University General Hospital</investigator_affiliation>
      <investigator_full_name>Jiayue Ding</investigator_full_name>
      <investigator_title>Principle investigator</investigator_title>
    </responsible_party>
    <keyword>brian infarction</keyword>
    <keyword>thrombolysis</keyword>
    <keyword>haemodilution</keyword>
    <keyword>normal saline</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Infarction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will share study protocol and statistical analysis plan with other researchers.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>One years after publications.</ipd_time_frame>
    </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/NCT05993078
  org study id: NS-STAR-1
  nct id: NCT05993078
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to explore the safety and efficacy of 0.9% normal saline （NS） infusion on
        stroke after intravenous thrombolysis (IVT), we decided to conduct this multi-centre
        randomized controlled trial for the first time. This trial will provide an innovative
        strategy to facilitate functional independence after stroke administered with IVT. This is a
        multi-center, randomized controlled two arm (1:1 ratio) clinical trial. The enrolled
        participators will be divided into NS group and control group randomly after confirming as
        acute ischemic stroke (AIS) according to symptoms and signs. In NS group, the patient will
        undergo NS 2000ml intravenous infusion swiftly after IVT, with the speed of 200ml/h. In
        control group, the patient will not undergo NS intravenous infusion after IVT. The primary
        efficacy is disability at days 90, as scored by means of the modified Rankin scale (mRS),
        dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score
        of 2 to 6). The secondary outcomes mainly comprise neurological deficits, disability, imaging
        and laboratory tests at each follow-up time. The safety outcomes include the cerebral edema
        at 24-hour post-IVT detected by cranial CT, the 24-hour fluctuation of blood pressure and the
        cardiac function detected by ultrasonic cardiogram within 3 days after IVT. Stata 15.1 and R
        software will be used for statistical analysis
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: 90-day favorable outcome
  time frame: 90 days
  description: Disability at days 90, as scored by means of the modified Rankin scale (mRS), dichotomized as a favorable outcome (a score of 0 or 1), or an unfavorable outcome (a score of 2 to 6). Scores on mRS range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
  measure: NIHSS scores at 24 hours
  time frame: 24 hours
  description: The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (<5, mild impairment; ≥25, very severe neurologic impairment).
  measure: NIHSS scores at days 7
  time frame: 7 days
  description: The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts (<5, mild impairment; ≥25, very severe neurologic impairment).
  measure: mRS at days 7
  time frame: 7 days
  description: Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
  measure: mRS at days 30
  time frame: 30 days
  description: Scores on the modified Rankin scale(mRS) range from 0 (no symptoms at all) to 6 (death), with higher values reflecting more severe disability or death.
  measure: volume of infarction at 24 hours
  time frame: 24 hours
  measure: early neurological deterioration
  time frame: 24 hours
  description: Early neurological deterioration indicates an increase of 4 or more points on the NIHSS score within 24 hours after IVT, and the deterioration is not caused by intracranial hemorrhage that is confirmed by cranial CT. The National Institutes of Health Stroke Scale (NIHSS), a 15-item scale that measures the level of neurologic impairment. Total scores on the NIHSS range from 0 to 42, with higher values reflecting more severe cerebral infarcts.
  arm group label: NS group
  arm group type: Experimental
  description: The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.
  arm group label: Control group
  arm group type: Placebo Comparator
  description: The patient will not undergo 0.9% NaCl intravenous infusion after IVT.
  intervention type: Drug
  intervention name: 0.9% NaCl 2000ml
  description: The patient will undergo NS 2000ml intravenous infusion swiftly after IVT.
  arm group label: NS group
  intervention type: Drug
  intervention name: 0.9% NaCl 0ml
  description: The patient will not undergo 0.9% NaCl intravenous infusion after IVT.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Tianjin Medical University General Hospital
  investigator full name: Jiayue Ding
  investigator title: Principle investigator
  mesh term: Brain Infarction
  sharing ipd: Yes
  ipd description: We will share study protocol and statistical analysis plan with other researchers.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: One years after publications.