<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/NCT03260153</url>
  </required_header>
  <id_info>
    <org_study_id>CBS-ICH</org_study_id>
    <nct_id>NCT03260153</nct_id>
  </id_info>
  <brief_title>Deproteinised Calf Blood Serum Injection for the Treatment of Acute Intracerebral Hemorrhage</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Stroke Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf&#xD;
      Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as&#xD;
      well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study hypothesized that administration of Deproteinised Calf Blood Serum Injection would&#xD;
      alleviate PHE and secondary brain injury, thus improving clinical outcomes in patients with&#xD;
      ICH. The investigators will enroll 60 acute supratentorial ICH patients. Patients will be&#xD;
      assigned randomly to receive either Deproteinised Calf Blood Serum Injection or placebo&#xD;
      treatment, which is blinded to evaluator and patients. All patients in the study will receive&#xD;
      standard care treatment and clinical, diagnostic, laboratory, safety, and follow-up&#xD;
      evaluations. Blood will be drawn and brain MRI will be done in different time course.&#xD;
      Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Stroke&#xD;
      impact scale , Glasgow Coma Scale ,Barthel index score and modified Rankin scale assessments,&#xD;
      will be done periodically until 90 days after onset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <primary_completion_date type="Anticipated">December 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)</measure>
    <time_frame>day 3, day 7-10</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of vasogenic edema on day 14 (CT evaluation)</measure>
    <time_frame>day 14</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of the biomarkers（MMP3、MMP9、TNF-α、IL-6、CRP） in the peripheral blood on different time course.</measure>
    <time_frame>at admission, day 3，day 3-7，day 14，day 30, day 90</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.</measure>
    <time_frame>at admission, day 14， day 30， day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.</measure>
    <time_frame>at admission, day 14， day 30， day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome evaluated by Barthel Index(BI) scores.</measure>
    <time_frame>day 14， day 30， day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.</measure>
    <time_frame>at admission, day 14， day 30， day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.</measure>
    <time_frame>day 90</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Intracerebral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Deproteinised Calf Blood Serum Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium Chloride Physiological Solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deproteinised Calf Blood Serum Injection</intervention_name>
    <arm_group_label>Deproteinised Calf Blood Serum Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (Sodium Chloride)</intervention_name>
    <arm_group_label>Sodium Chloride Physiological Solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of spontaneous intracerebral hemorrhage(sICH)&#xD;
&#xD;
          2. Bleeding into deep gray matter (basal ganglionic and thalamus), and the amount of&#xD;
             bleeding between 5 and 30 ml;&#xD;
&#xD;
          3. Age between 18 and 80 years;&#xD;
&#xD;
          4. Presentation within 48 hours of symptom onset, and NCCT at 24 hours need to be done in&#xD;
             patients presenting within 24 hours of symptom onset in order to exclude hematoma&#xD;
             expansion.&#xD;
&#xD;
          5. Informed consent by patients or relatives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Â secondary ICH (secondary to trauma, tumor, vascular malformations, ischemic stroke&#xD;
             hemorrhagic transformation, etc.);&#xD;
&#xD;
          2. Glasgow Coma Score of 3-8 at admission;&#xD;
&#xD;
          3. Parenchymal hemorrhage with ventricle involved;&#xD;
&#xD;
          4. Patients with hematoma expansion; .&#xD;
&#xD;
          5. Planned surgery within 3 days of symptom onset;&#xD;
&#xD;
          6. Incompletely absorbed brain hematoma previously;&#xD;
&#xD;
          7. Prestroke modified Rankin score(mRS)&gt;1;&#xD;
&#xD;
          8. Patients with hemorrhagic disease or coagulation disorders;&#xD;
&#xD;
          9. Patients with severe liver and renal insufficiency;.&#xD;
&#xD;
         10. Patients with severe heart failure or other serious systemic diseases;&#xD;
&#xD;
         11. Patients with malignant tumors or ongoing anti-tumor therapy;&#xD;
&#xD;
         12. Patients with a history of dementia or mental disorders;&#xD;
&#xD;
         13. Pregnant or lactating women or those who has a recent fertility plan;&#xD;
&#xD;
         14. Any contraindications to MRI(such as cardiac pacemakers and other metal implants,&#xD;
             claustrophobia);&#xD;
&#xD;
         15. Any other neuroprotective has been applied before randomization;&#xD;
&#xD;
         16. Terminal patients whose life expectancy &lt;90 days;&#xD;
&#xD;
         17. Patients participating in other clinical trials 30 days prior to randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xingquan Zhao, MD</last_name>
    <phone>8610-67098891</phone>
    <email>zxq@vip.163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Tian Tan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xingquan Zhao, MD</last_name>
      <phone>8610-67098891</phone>
      <email>zxq@vip.163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Xingquan Zhao</investigator_full_name>
    <investigator_title>Professor of Neurology and Stroke Center</investigator_title>
  </responsible_party>
  <keyword>Intracerebral Hemorrhage</keyword>
  <keyword>Perihematomal edema</keyword>
  <keyword>Deproteinised Calf Blood Serum Injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03260153
org study id: CBS-ICH
nct id: NCT03260153
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the efficacy and safety of Deproteinised Calf
      Blood Serum Injection in alleviating perihematomal edema (PHE) and secondary brain injury, as
      well as neurologic deficits in patients with acute intracerebral hemorrhage (ICH).
The study hypothesized that administration of Deproteinised Calf Blood Serum Injection would
      alleviate PHE and secondary brain injury, thus improving clinical outcomes in patients with
      ICH. The investigators will enroll 60 acute supratentorial ICH patients. Patients will be
      assigned randomly to receive either Deproteinised Calf Blood Serum Injection or placebo
      treatment, which is blinded to evaluator and patients. All patients in the study will receive
      standard care treatment and clinical, diagnostic, laboratory, safety, and follow-up
      evaluations. Blood will be drawn and brain MRI will be done in different time course.
      Follow-up evaluations, including National Institute of Health stroke scale(NIHSS), Stroke
      impact scale , Glasgow Coma Scale ,Barthel index score and modified Rankin scale assessments,
      will be done periodically until 90 days after onset.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Changes of cytotoxic and vasogenic edema on day 3 and day 7-10 (MRI evaluation)
time frame: day 3, day 7-10
measure: Changes of vasogenic edema on day 14 (CT evaluation)
time frame: day 14
measure: Changes of the biomarkers（MMP3、MMP9、TNF-α、IL-6、CRP） in the peripheral blood on different time course.
time frame: at admission, day 3，day 3-7，day 14，day 30, day 90
measure: Clinical outcome evaluated by Glasgow Coma Scale(GCS)scores.
time frame: at admission, day 14， day 30， day 90
measure: Clinical outcome evaluated by NIH Stroke Scale(NIHSS)scores.
time frame: at admission, day 14， day 30， day 90
measure: Clinical outcome evaluated by Barthel Index(BI) scores.
time frame: day 14， day 30， day 90
measure: Clinical outcome evaluated by Modified Rankin Scale(mRS)scores.
time frame: at admission, day 14， day 30， day 90
measure: Clinical outcome evaluated by Stroke Impact Scale (SIS) scores.
time frame: day 90
arm group label: Deproteinised Calf Blood Serum Injection
arm group type: Experimental
description: Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.
arm group label: Sodium Chloride Physiological Solution
arm group type: Placebo Comparator
description: Participants will be randomly assigned to receive Deproteinised Calf Blood Serum Injection or placebo within 1 hour after randomization, once a day for 14 days.
intervention type: Drug
intervention name: Deproteinised Calf Blood Serum Injection
arm group label: Deproteinised Calf Blood Serum Injection
intervention type: Drug
intervention name: Placebo (Sodium Chloride)
arm group label: Sodium Chloride Physiological Solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xingquan Zhao, MD
phone: 8610-67098891
email: zxq@vip.163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Xingquan Zhao
investigator title: Professor of Neurology and Stroke Center
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage