<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/NCT02192320</url>
  </required_header>
  <id_info>
    <org_study_id>CSDH2014</org_study_id>
    <nct_id>NCT02192320</nct_id>
  </id_info>
  <brief_title>The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders</brief_title>
  <official_title>The Clinical Study of Atorvastatin and Dexamethasone on Treatment for Chronic Subdural Hematoma in the Patients With Coagulation Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oriental Neurosurgery Evidence-Based-Study Team</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oriental Neurosurgery Evidence-Based-Study Team</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative&#xD;
      treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Two-arm,Evaluator-blinded study&#xD;
&#xD;
      Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）&#xD;
&#xD;
      Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in&#xD;
      Atorvastatin-treated group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of hematoma volume</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
    <description>After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Outcome score (GOSE) in subjects</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of neurological symptoms and signs</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence and prognosis of patient failure in those conservative treatment</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome score (ADL-BI Scale) in subjects</measure>
    <time_frame>2,5,12 weeks during treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Chronic Subdural Hematoma</condition>
  <arm_group>
    <arm_group_label>Atorvastatin and Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin: 20 mg (every evening orally) for 5 weeks;&#xD;
Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atorvastatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atorvastatin: 20 mg (every evening orally) for 5 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>20 mg (every evening orally) for 5 weeks</description>
    <arm_group_label>Atorvastatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin and Dexamethasone</intervention_name>
    <description>Atorvastatin: 20 mg (every evening orally) for 5 weeks;&#xD;
Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)</description>
    <arm_group_label>Atorvastatin and Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 and&lt;90years old, both gender;&#xD;
&#xD;
          2. Long-term antiplatelet and anticoagulant drugs cause Coagulation Disorders;&#xD;
&#xD;
          3. CT scan reveals supratentorial, unilateral or bilateral chronic subdural hematoma (MRI&#xD;
             scan is warranted if diagnosis is difficult);&#xD;
&#xD;
          4. The midline shift to less than 1 cm;&#xD;
&#xD;
          5. Attending physician makes a judgment that cerebral hernia would not occur and surgical&#xD;
             operation might not be performed in a short time. Conservative treatment is adopted;&#xD;
&#xD;
          6. Patients have never undergo surgery on the hematoma;&#xD;
&#xD;
          7. Patient fully understood the nature of the study, and voluntarily participates and&#xD;
             signs informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Allergic to the statin and dexamethasone or its ingredients;&#xD;
&#xD;
          2. Hematoma caused by tumors, blood and other known comorbidities;&#xD;
&#xD;
          3. Abnormal liver function;&#xD;
&#xD;
          4. Uncontrolled hepatitis and other liver diseases, as well as suffering from other&#xD;
             disease may interfere the study;&#xD;
&#xD;
          5. Patients have been on oral Statin treatment in the past four weeks;&#xD;
&#xD;
          6. Patients have been on oral Steroids treatment for a long time;&#xD;
&#xD;
          7. Diagnosed Diabetes patients with poorly controlled blood glucose&#xD;
&#xD;
          8. Participate in clinical trials in the past four weeks;&#xD;
&#xD;
          9. Pregnant or breastfeeding;&#xD;
&#xD;
         10. Failure of completing the trial by poor compliance;&#xD;
&#xD;
         11. For any reason, the researchers believe that the case is not suitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rongcai Jiang, PhD</last_name>
    <phone>86-22-60814348</phone>
    <email>jianghope@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atorvastatin</keyword>
  <keyword>Atorvastatin and Dexamethasone</keyword>
  <keyword>Chronic Subdural Hematoma</keyword>
  <keyword>conservative treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma, Subdural</mesh_term>
    <mesh_term>Hematoma, Subdural, Chronic</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_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/NCT02192320
org study id: CSDH2014
nct id: NCT02192320
lead sponsor: 
has dmc: No
To evaluate Efficacy and Safety of oral Atorvastatin and Dexamethasone on conservative
      treatment for Chronic Subdural Hematoma (CSDH) patients with Coagulation Disorders
Study design: Two-arm,Evaluator-blinded study

      Subjects: CSDH patients with Coagulation Disorders（Conservative treatment is adopted）

      Sample size: 60 cases, 30 in Atorvastatin and Dexamethasone-treated group, 30 in
      Atorvastatin-treated group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes of hematoma volume
time frame: 2,5,12 weeks during treatment
description: After 5 weeks' treatment, the hematoma will be assessed, then the therapy will be continued according to follow-up processes.Head CT to all the patients will be performed before the treatment, after the 2nd week and 5th week during treatment (at the end), at the 12th week during the follow-up.
measure: Outcome score (GOSE) in subjects
time frame: 2,5,12 weeks during treatment
measure: Changes of peripheral blood for later tested SDF-1a, Treg, CXCR4 and related analysis
time frame: 2,5,12 weeks during treatment
measure: Changes of neurological symptoms and signs
time frame: 2,5,12 weeks during treatment
measure: Recurrence and prognosis of patient failure in those conservative treatment
time frame: 2,5,12 weeks during treatment
measure: Outcome score (ADL-BI Scale) in subjects
time frame: 2,5,12 weeks during treatment
arm group label: Atorvastatin and Dexamethasone
arm group type: Experimental
description: Atorvastatin: 20 mg (every evening orally) for 5 weeks;
Dexamethasone: 0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
arm group label: Atorvastatin
arm group type: Active Comparator
description: Atorvastatin: 20 mg (every evening orally) for 5 weeks
intervention type: Drug
intervention name: Atorvastatin
description: 20 mg (every evening orally) for 5 weeks
arm group label: Atorvastatin
intervention type: Drug
intervention name: Atorvastatin and Dexamethasone
description: Atorvastatin: 20 mg (every evening orally) for 5 weeks;
Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)
arm group label: Atorvastatin and Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Rongcai Jiang, PhD
phone: 86-22-60814348
email: jianghope@gmail.com
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Hematoma, Subdural
mesh term: Hematoma, Subdural, Chronic
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hematoma
mesh term: Dexamethasone
mesh term: Atorvastatin