<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/NCT04450446</url>
  </required_header>
  <id_info>
    <org_study_id>2020-315</org_study_id>
    <nct_id>NCT04450446</nct_id>
  </id_info>
  <brief_title>Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves</brief_title>
  <official_title>Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang 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 investigators retrospectively reviewed the electronic medical records of the patients&#xD;
      with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second&#xD;
      affiliated hospital of Zhejiang university medical college. Medical documents and patient&#xD;
      data were reviewed, including patient age, gender, type of mechanical heart valve,&#xD;
      replacement time, replacement site, underlying disease, anticoagulant drugs at admission,&#xD;
      type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay,&#xD;
      mortality, etc&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">August 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>survival and death patients after follow-up investigation for 60 months</measure>
    <time_frame>2015-2020</time_frame>
    <description>the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cerebral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>cerebral hemorrhage</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>thromboembolism</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>no thromboembolism and cerebral hemorrhage</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low molecular weight heparin</intervention_name>
    <description>Anticoagulation therapy</description>
    <arm_group_label>cerebral hemorrhage</arm_group_label>
    <arm_group_label>no thromboembolism and cerebral hemorrhage</arm_group_label>
    <arm_group_label>thromboembolism</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the patients with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020&#xD;
        in the second affiliated hospital of Zhejiang university medical college.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with spontaneous cerebral hemorrhage and mechanical valves&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18y&#xD;
&#xD;
          -  pregnant patients&#xD;
&#xD;
          -  death in 24 hours without anticoagulant&#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_official>
    <last_name>libin li, MD</last_name>
    <role>Study Director</role>
    <affiliation>second affiliated hospital,school of medicine, zhejiang university,china</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>rubin luo, MD</last_name>
    <phone>+86057187783759</phone>
    <email>keyanlunli_zheer@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Second Affiliated Hospital, School of Medicine, Zhejiang University, China</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital,School of Medicine, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Tinzaparin</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04450446
org study id: 2020-315
nct id: NCT04450446
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators retrospectively reviewed the electronic medical records of the patients
      with spontaneous cerebral hemorrhage and mechanical valves from 2015 to 2020 in the second
      affiliated hospital of Zhejiang university medical college. Medical documents and patient
      data were reviewed, including patient age, gender, type of mechanical heart valve,
      replacement time, replacement site, underlying disease, anticoagulant drugs at admission,
      type of cerebral hemorrhage, treatment mode, time without anticoagulant, length of stay,
      mortality, etc
observational model: Case-Control
time perspective: Retrospective
measure: survival and death patients after follow-up investigation for 60 months
time frame: 2015-2020
description: the patients with spontaneous cerebral hemorrhage and mechanical valves in the second affiliated hospital of Zhejiang university medical college.
arm group label: cerebral hemorrhage
arm group label: thromboembolism
arm group label: no thromboembolism and cerebral hemorrhage
intervention type: Drug
intervention name: Low molecular weight heparin
description: Anticoagulation therapy
arm group label: cerebral hemorrhage
arm group label: no thromboembolism and cerebral hemorrhage
arm group label: thromboembolism
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: libin li, MD
role: Study Director
affiliation: second affiliated hospital,school of medicine, zhejiang university,china
last name: rubin luo, MD
phone: +86057187783759
email: keyanlunli_zheer@163.com
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
mesh term: Heparin
mesh term: Heparin, Low-Molecular-Weight
mesh term: Tinzaparin
mesh term: Dalteparin
sharing ipd: No