<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/NCT04486859</url>
  </required_header>
  <id_info>
    <org_study_id>KY2020-794</org_study_id>
    <nct_id>NCT04486859</nct_id>
  </id_info>
  <brief_title>Postoperative Thrombosis Prevention in Patients With CD</brief_title>
  <official_title>A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huashan Hospital</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>
      Patients with Cushing disease was randomized to 2 groups. After surgery, the patients were&#xD;
      managed with mechanical prevention or mechanical prevention plus anticoagulant drugs(LMWH&#xD;
      followed by rivaroxaban), VTE was observed 24h, 5day, 4weeks and 12weeks after&#xD;
      surgery.Bleeding events were also recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cushing disease, caused by ACTH-secreting pituitary adenomas, can lead to serious&#xD;
      complications with increased mortality. Minimally invasive surgery is currently the preferred&#xD;
      treatment for the disease, allowing more than 80% of tumors to be completely removed.&#xD;
      However, postoperative venous thrombosis (VTE), including deep vein thrombosis (DVT) and&#xD;
      pulmonary embolism (PE) pose great threats to patients' safety. According to the literatures&#xD;
      and the data from our center, up to 27% of the patients with Cushing's disease developed VTE&#xD;
      after surgery. Due to the lacking of a randomized prospective study, there is no consensus or&#xD;
      guideline on preventative anticoagulation protocols for postoperative management in patients&#xD;
      with Cushing's disease. This is a prospective randomized control study on preventative&#xD;
      anticoagulation in patients with Cushing's disease after transsphenoidal resection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2023</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VTE incidence rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>DVT and PE incidence in 12 weeks after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DVT incidence rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>DVT in 12 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PE incidence rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>PE in 12 weeks after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 weeks</time_frame>
    <description>All-cause Mortality and VTE-specific Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic VTE incidence rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Symptomatic DVT and PE incidence in 12 weeks after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">206</enrollment>
  <condition>Cushing Disease</condition>
  <condition>DVT</condition>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>mechanical prevention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients were managed with IPC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mechanical plus anticoagulant drugs prevention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LMWH/Rivaroxaban</intervention_name>
    <description>combined prevention</description>
    <arm_group_label>mechanical plus anticoagulant drugs prevention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IPC</intervention_name>
    <description>mechanical prevention</description>
    <arm_group_label>mechanical plus anticoagulant drugs prevention</arm_group_label>
    <arm_group_label>mechanical prevention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cushing's disease patient diagnosed and treated with transsphenoid surgery at study&#xD;
             centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with thrombosis before surgery;&#xD;
&#xD;
          -  patients with cute bacterial endocarditis,&#xD;
&#xD;
          -  thrombocytopenia,&#xD;
&#xD;
          -  active peptic ulcer,&#xD;
&#xD;
          -  with contraindications to Rivaroxaban;&#xD;
&#xD;
          -  patients whose cranial MRA or CTA prompts abnormalities in intracranial blood vessels&#xD;
             which may be at risk of intracranial hemorrhage;&#xD;
&#xD;
          -  patients with coagulation abnormalities suggesting a high risk of bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haijun Wang</last_name>
      <phone>020-87755766</phone>
      <email>XXX@sysu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Juan Chen</last_name>
      <phone>027-83665555</phone>
      <email>XXX@mail.hust.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao Zhao</last_name>
      <phone>86-13916872553</phone>
      <email>zhaoyaohs@vip.sina.com</email>
    </contact>
    <investigator>
      <last_name>Yao Zhao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huijuan Zhu</last_name>
      <phone>010-69156114</phone>
      <email>XXX@pumch.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 10, 2022</last_update_submitted>
  <last_update_submitted_qc>July 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Zhaoyun Zhang</investigator_full_name>
    <investigator_title>vice director of endocrine department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>ACTH-Secreting Pituitary Adenoma</mesh_term>
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Pituitary ACTH Hypersecretion</mesh_term>
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivaroxaban</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/NCT04486859
org study id: KY2020-794
nct id: NCT04486859
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Patients with Cushing disease was randomized to 2 groups. After surgery, the patients were
      managed with mechanical prevention or mechanical prevention plus anticoagulant drugs(LMWH
      followed by rivaroxaban), VTE was observed 24h, 5day, 4weeks and 12weeks after
      surgery.Bleeding events were also recorded.
Cushing disease, caused by ACTH-secreting pituitary adenomas, can lead to serious
      complications with increased mortality. Minimally invasive surgery is currently the preferred
      treatment for the disease, allowing more than 80% of tumors to be completely removed.
      However, postoperative venous thrombosis (VTE), including deep vein thrombosis (DVT) and
      pulmonary embolism (PE) pose great threats to patients' safety. According to the literatures
      and the data from our center, up to 27% of the patients with Cushing's disease developed VTE
      after surgery. Due to the lacking of a randomized prospective study, there is no consensus or
      guideline on preventative anticoagulation protocols for postoperative management in patients
      with Cushing's disease. This is a prospective randomized control study on preventative
      anticoagulation in patients with Cushing's disease after transsphenoidal resection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: VTE incidence rate
time frame: 12 weeks
description: DVT and PE incidence in 12 weeks after surgery
measure: DVT incidence rate
time frame: 12 weeks
description: DVT in 12 weeks after surgery
measure: PE incidence rate
time frame: 12 weeks
description: PE in 12 weeks after surgery
measure: Mortality
time frame: 12 weeks
description: All-cause Mortality and VTE-specific Mortality
measure: Symptomatic VTE incidence rate
time frame: 12 weeks
description: Symptomatic DVT and PE incidence in 12 weeks after surgery
arm group label: mechanical prevention
arm group type: Other
description: patients were managed with IPC
arm group label: mechanical plus anticoagulant drugs prevention
arm group type: Other
description: patients were managed with IPC, and LMWH was added 24h after surgery and followed by rivaroxaban 5 days after surgery
intervention type: Drug
intervention name: LMWH/Rivaroxaban
description: combined prevention
arm group label: mechanical plus anticoagulant drugs prevention
intervention type: Device
intervention name: IPC
description: mechanical prevention
arm group label: mechanical plus anticoagulant drugs prevention
arm group label: mechanical prevention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Zhaoyun Zhang
investigator title: vice director of endocrine department
mesh term: ACTH-Secreting Pituitary Adenoma
mesh term: Pulmonary Embolism
mesh term: Pituitary ACTH Hypersecretion
mesh term: Thrombosis
mesh term: Embolism
mesh term: Rivaroxaban