<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/NCT03306823</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1301800-Anticoagulation</org_study_id>
    <nct_id>NCT03306823</nct_id>
  </id_info>
  <brief_title>Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1</brief_title>
  <acronym>EAPCAAMHO1</acronym>
  <official_title>Multi-center, Single-blind, Prospective Cohort Study of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital of Fujian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fujian Medical University Union Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Tiantan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the stage of registration study, our purpose is to find out the safety range of activated&#xD;
      coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid&#xD;
      operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation&#xD;
      and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two&#xD;
      parts, and each part divide into two stage, on the stage of registration study. This study is&#xD;
      a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative&#xD;
      activated coagulation time Changes in detail, to observe the effect of activated coagulation&#xD;
      time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours,&#xD;
      purpose to find out the safety range of activated coagulation time level in cerebral aneurysm&#xD;
      and arteriovenous malformations with hybrid operation. On the stage of randomized controlled&#xD;
      study. This study is a multicenter, single-blind, prospective, randomized controlled study.&#xD;
      Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose&#xD;
      group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens&#xD;
      on activated coagulation time safety coverage rate during surgery, and finally develop a&#xD;
      scientific and effective intraoperative anticoagulant therapy program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery</measure>
    <time_frame>From the beginning of surgery to 48 hours after surgery</time_frame>
    <description>Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery</measure>
    <time_frame>From the beginning of surgery to 48 hours after surgery</time_frame>
    <description>Ischemia event include Cerebral infarction and transient ischemic attack.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>During the surgery</time_frame>
    <description>All the blood lost during the surgery should be collected and measured.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">556</enrollment>
  <condition>Cerebral Aneurysm</condition>
  <condition>Arteriovenous Malformations</condition>
  <arm_group>
    <arm_group_label>aneurysm</arm_group_label>
    <description>For cerebral aneurysm with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arteriovenous malformations</arm_group_label>
    <description>For arteriovenous malformations with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators chose the patiens from the Tiantan hospital and other hospitals that&#xD;
        participated in this study.The patients diagnosed as cerebral aneurysm and arteriovenous&#xD;
        malformations,and take part in hybrid operation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.All patients undergoing hybird surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Poor general condition , severe primary disease, surgical contraindications&#xD;
&#xD;
          2. Patient or family refused surgery&#xD;
&#xD;
          3. Fusiform aneurysm,Traumatic aneurysm,Infectious aneurysms&#xD;
&#xD;
          4. Combined with other hemorrhagic cerebrovascular disease&#xD;
&#xD;
          5. Combined with malignant brain tumor&#xD;
&#xD;
          6. Perinatal, Pregnancy&#xD;
&#xD;
          7. Patients unwilling to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yong Cao, Doctor</last_name>
    <phone>010-67096510</phone>
    <email>caoyong6@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Tiantan 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>Yong Cao, M.D.</last_name>
      <phone>010-67096523</phone>
      <phone_ext>100050</phone_ext>
      <email>caoyong6@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>May 31, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tiantan Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Yong Cao</investigator_full_name>
    <investigator_title>Principal</investigator_title>
  </responsible_party>
  <keyword>Cerebral Aneurysm</keyword>
  <keyword>Arteriovenous Malformations</keyword>
  <keyword>Hybrid operation</keyword>
  <keyword>Anticoagulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemangioma</mesh_term>
    <mesh_term>Intracranial Aneurysm</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Arteriovenous Malformations</mesh_term>
    <mesh_term>Congenital Abnormalities</mesh_term>
  </condition_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/NCT03306823
org study id: 2016YFC1301800-Anticoagulation
nct id: NCT03306823
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the stage of registration study, our purpose is to find out the safety range of activated
      coagulation time level in cerebral aneurysm and arteriovenous malformations with hybrid
      operation.
This study is divided into anticoagulation program in cerebral aneurysm with hybrid operation
      and anticoagulation program in cerebral arteriovenous malformations with hybrid operation two
      parts, and each part divide into two stage, on the stage of registration study. This study is
      a multi-center, single-blind, prospective cohort study. Record the patient's intraoperative
      activated coagulation time Changes in detail, to observe the effect of activated coagulation
      time maintenance level on hemorrhage event rate of Intraoperative and postoperative 48 hours,
      purpose to find out the safety range of activated coagulation time level in cerebral aneurysm
      and arteriovenous malformations with hybrid operation. On the stage of randomized controlled
      study. This study is a multicenter, single-blind, prospective, randomized controlled study.
      Patients is divided into intraoperative standard dose group of Heparin Sodium and low dose
      group of Heparin Sodium randomly. To observe the effect of different anticoagulation regimens
      on activated coagulation time safety coverage rate during surgery, and finally develop a
      scientific and effective intraoperative anticoagulant therapy program.
observational model: Cohort
time perspective: Prospective
measure: Changes in hemorrhage event rate from the beginning of surgery to 48 hours after surgery
time frame: From the beginning of surgery to 48 hours after surgery
description: Hemorrhage event include intracranial hemorrhage caused by non-surgical reasons, as well as other organs or parts of the massive bleeding or small bleeding, Including subperitoneal hemorrhage, intraocular hemorrhage, gross hematuria, epistaxis time prolonged or repeated, gastrointestinal bleeding, hemoptysis, subconjunctival hemorrhage, hematoma greater than 5cm, bleeding difficult to control the and so on.
measure: Changes in ischemia event rate from the beginning of surgery to 48 hours after surgery
time frame: From the beginning of surgery to 48 hours after surgery
description: Ischemia event include Cerebral infarction and transient ischemic attack.
measure: Intraoperative blood loss
time frame: During the surgery
description: All the blood lost during the surgery should be collected and measured.
arm group label: aneurysm
description: For cerebral aneurysm with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.
arm group label: arteriovenous malformations
description: For arteriovenous malformations with hybrid operation, anticoagulation program is decided by different surgeons based on their experience and record the patient's intraoperative activated coagulation time changes in detail.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: No
last name: Yong Cao, Doctor
phone: 010-67096510
email: caoyong6@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tiantan Hospital
investigator full name: Dr. Yong Cao
investigator title: Principal
mesh term: Hemangioma
mesh term: Intracranial Aneurysm
mesh term: Aneurysm
mesh term: Arteriovenous Malformations
mesh term: Congenital Abnormalities
sharing ipd: No