<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/NCT03306836</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1301800-2</org_study_id>
    <nct_id>NCT03306836</nct_id>
  </id_info>
  <brief_title>Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2</brief_title>
  <acronym>EAPCAAMHO2</acronym>
  <official_title>Multi-center，Single Blind，Prospective Randomized Controlled Trial 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 randomized controlled study, our purpose is to obtain the Intraoperative&#xD;
      anticoagulation program supported by evidence-based medicine.&#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>
  <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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in activated coagulation time safety coverage 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>Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.</description>
  </primary_outcome>
  <secondary_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>
  </secondary_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>From the beginning of surgery to 48 hours after surgery</time_frame>
    <description>All the blood lost during the surgery should be collected and measured.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">408</enrollment>
  <condition>Cerebral Aneurysm</condition>
  <condition>Arteriovenous Malformations</condition>
  <arm_group>
    <arm_group_label>Standard dose group of Heparin Sodium</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose group of Heparin Sodium</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin Sodium</intervention_name>
    <description>Infused with 5000 IU of Heparin Sodium</description>
    <arm_group_label>Standard dose group of Heparin Sodium</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Heparin Sodium</intervention_name>
    <description>Infusion Heparin Sodium at a rate of 18 IU / kg.h</description>
    <arm_group_label>Low dose group of Heparin Sodium</arm_group_label>
    <arm_group_label>Standard dose group of Heparin Sodium</arm_group_label>
  </intervention>
  <eligibility>
    <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>
    <investigator>
      <last_name>Yong Cao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Hybrid operation</keyword>
  <keyword>Cerebral Aneurysm</keyword>
  <keyword>Arteriovenous Malformations</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Calcium heparin</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/NCT03306836
org study id: 2016YFC1301800-2
nct id: NCT03306836
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the stage of randomized controlled study, our purpose is to obtain the Intraoperative
      anticoagulation program supported by evidence-based medicine.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in activated coagulation time safety coverage rate from the beginning of surgery to 48 hours after surgery
time frame: From the beginning of surgery to 48 hours after surgery
description: Activated coagulation time average value falls in the safety coverage rate from the beginning of surgery to 48 hours after surgery.
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: From the beginning of surgery to 48 hours after surgery
description: All the blood lost during the surgery should be collected and measured.
arm group label: Standard dose group of Heparin Sodium
arm group type: Experimental
description: First infused with 5000 IU of Heparin Sodium, then continuous infusion at a rate of 18 IU / kg.h during the hybrid operation.
arm group label: Low dose group of Heparin Sodium
arm group type: Active Comparator
description: infusion Heparin Sodium at a rate of 18 IU / kg.h during the hybrid operation.
intervention type: Drug
intervention name: Heparin Sodium
description: Infused with 5000 IU of Heparin Sodium
arm group label: Standard dose group of Heparin Sodium
intervention type: Drug
intervention name: Heparin Sodium
description: Infusion Heparin Sodium at a rate of 18 IU / kg.h
arm group label: Low dose group of Heparin Sodium
arm group label: Standard dose group of Heparin Sodium
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: 
investigator: 
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
mesh term: Heparin
mesh term: Calcium heparin
sharing ipd: No