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/NCT05990894</url>
    </required_header>
    <id_info>
      <org_study_id>[2020]098</org_study_id>
      <nct_id>NCT05990894</nct_id>
    </id_info>
    <brief_title>Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.</brief_title>
    <official_title>Efficacy and Safety of Steroid for Treatment of Acute/Subacute Severe Cerebral Venous Thrombosis.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xuanwu Hospital, Beijing</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xuanwu Hospital, Beijing</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The cohort study aims to evaluate the efficacy and safety of steroids combined with&#xD;
        anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe&#xD;
        cerebral venous thrombosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: Evidence suggests that the inflammatory response plays a crucial role in&#xD;
        regulating severe CVT pathogenesis. However, whether CVT patients can benefit from&#xD;
        anti-inflammatory therapy has been debated.&#xD;
  &#xD;
        Objective: The objective of this cohort study is to explore the efficacy and safety of&#xD;
        steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in&#xD;
        acute/subacute severe cerebral venous thrombosis (CVT) patients.&#xD;
  &#xD;
        Method: We reviewed the data of patients with acute/subacute severe CVT treated with a&#xD;
        short-term application of steroid or not from a prospective stroke registry of our center. We&#xD;
        compared functional outcomes and major adverse events at 6 months follow-up after discharge.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">December 31, 2021</completion_date>
    <primary_completion_date type="Actual">December 31, 2021</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>modified Rankin score(mRS)</measure>
      <time_frame>6 months after discharge</time_frame>
      <description>mRS score &gt;2 indicates poor prognosis and mRS score ≤2 indicates favorable outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recurrence of CVT</measure>
      <time_frame>6 months after discharge</time_frame>
      <description>Diagnosed by MRI/MRBTI/MRV, CTV, or DSA.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serious steroids complications</measure>
      <time_frame>6 months after discharge</time_frame>
      <description>Lower extremity deep venous thrombosis.&#xD;
  Pulmonary embolism&#xD;
  Spontaneous fractures or osteonecrosis&#xD;
  Infection&#xD;
  gastroduodenal ulcer</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Residual symptoms</measure>
      <time_frame>6 months after discharge</time_frame>
      <description>Including headaches, visual disturbances, epilepsy, and current work status.</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">248</enrollment>
    <condition>Cerebral Venous Thrombosis</condition>
    <arm_group>
      <arm_group_label>Standard treatment group</arm_group_label>
      <description>Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Steroid therapy group</arm_group_label>
      <description>Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Methylprednisolone</intervention_name>
      <description>In the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week.</description>
      <arm_group_label>Steroid therapy group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with first-episode acute/subacute CVT were enrolled in a prospective stroke&#xD;
          registry at Xuanwu Hospital, Capital Medical University, from January 2018 to June 2021.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Acute (within 7 days after symptom onset) or subacute (8-15 days since symptom onset)&#xD;
               severe CVT diagnosed by MRI+MRV, CT+CTV, or DSA.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with malignancies&#xD;
  &#xD;
            -  Patients with incomplete follow-up data.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Jiangang Duan, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xuanwu Hospital, Beijing</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Xuanwu Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 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>Xuanwu Hospital, Beijing</investigator_affiliation>
      <investigator_full_name>JiangangDuan</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <keyword>Cerebral venous thrombosis</keyword>
    <keyword>Severe cerebral venous thrombosis</keyword>
    <keyword>Steroid therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombosis</mesh_term>
      <mesh_term>Venous Thrombosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methylprednisolone</mesh_term>
      <mesh_term>Methylprednisolone Acetate</mesh_term>
      <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
      <mesh_term>Prednisolone</mesh_term>
      <mesh_term>Prednisolone acetate</mesh_term>
      <mesh_term>Prednisolone hemisuccinate</mesh_term>
      <mesh_term>Prednisolone phosphate</mesh_term>
    </intervention_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/NCT05990894
  org study id: [2020]098
  nct id: NCT05990894
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The cohort study aims to evaluate the efficacy and safety of steroids combined with
        anticoagulant therapy compared to standard anticoagulant therapy in acute/subacute severe
        cerebral venous thrombosis.
  Background: Evidence suggests that the inflammatory response plays a crucial role in
        regulating severe CVT pathogenesis. However, whether CVT patients can benefit from
        anti-inflammatory therapy has been debated.
  
        Objective: The objective of this cohort study is to explore the efficacy and safety of
        steroids combined with anticoagulant therapy compared to standard anticoagulant therapy in
        acute/subacute severe cerebral venous thrombosis (CVT) patients.
  
        Method: We reviewed the data of patients with acute/subacute severe CVT treated with a
        short-term application of steroid or not from a prospective stroke registry of our center. We
        compared functional outcomes and major adverse events at 6 months follow-up after discharge.
  observational model: Cohort
  time perspective: Prospective
  measure: modified Rankin score(mRS)
  time frame: 6 months after discharge
  description: mRS score >2 indicates poor prognosis and mRS score ≤2 indicates favorable outcome.
  measure: Recurrence of CVT
  time frame: 6 months after discharge
  description: Diagnosed by MRI/MRBTI/MRV, CTV, or DSA.
  measure: Serious steroids complications
  time frame: 6 months after discharge
  description: Lower extremity deep venous thrombosis.
  Pulmonary embolism
  Spontaneous fractures or osteonecrosis
  Infection
  gastroduodenal ulcer
  measure: Residual symptoms
  time frame: 6 months after discharge
  description: Including headaches, visual disturbances, epilepsy, and current work status.
  arm group label: Standard treatment group
  description: Each patient received subcutaneous low-molecular-weight heparin in adjusted doses for 10 to 14 days, followed by oral anticoagulants (warfarin or dabigatran or rivaroxaban, if warfarin was used, PT-INR was maintained between 2.0 and 3.0) for 6 months or more. The use of endovascular treatment (local thrombectomy/thrombolysis) was reserved for patients who are still progressing with adequate anticoagulant therapy.
  arm group label: Steroid therapy group
  description: Patients in the steroid therapy group received short-term steroids in addition to standard anticoagulant therapy.
  intervention type: Drug
  intervention name: Methylprednisolone
  description: In the steroid therapy group, patients received standard treatment plus steroid therapy. Steroid therapy protocol is as follows: 500 mg methylprednisolone once a day, intravenous drip for 3 days, then reduced to 80 mg once a day, intravenous drip for 5 days, and changed to oral methylprednisolone/prednisone 1 mg per kilogram body weight, gradually tapered off by a dose of 10 mg per week.
  arm group label: Steroid therapy group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Jiangang Duan, MD, PhD
  role: Principal Investigator
  affiliation: Xuanwu Hospital, Beijing
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xuanwu Hospital, Beijing
  investigator full name: JiangangDuan
  investigator title: MD, PhD
  mesh term: Thrombosis
  mesh term: Venous Thrombosis
  mesh term: Methylprednisolone
  mesh term: Methylprednisolone Acetate
  mesh term: Methylprednisolone Hemisuccinate
  mesh term: Prednisolone
  mesh term: Prednisolone acetate
  mesh term: Prednisolone hemisuccinate
  mesh term: Prednisolone phosphate
  sharing ipd: No