<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/NCT03804697</url>
  </required_header>
  <id_info>
    <org_study_id>2016-46</org_study_id>
    <nct_id>NCT03804697</nct_id>
  </id_info>
  <brief_title>Selective Thromboembolism Prophylaxis After Arthroplasty</brief_title>
  <official_title>Selective Thromboembolism Prophylaxis After Total Hip Arthroplasty or Total Knee Arthroplasty by a Risk Stratification With Thromboelastography for Asian Populations: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's 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>
      Asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which&#xD;
      means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for&#xD;
      Caucasian populations may be too excessive for Asians. So, individual patient risk&#xD;
      assessment, rather than a &quot;blanket policy&quot;, is considered the best thromboembolism&#xD;
      prophylaxis for Asians.The purpose of this study was to evaluate the effectiveness and safety&#xD;
      of selective thromboembolism prophylaxis compared with conventional thromboembolism&#xD;
      prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty&#xD;
      for Asian populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asian patients who underwent hip or knee arthroplasty in Guangdong General Hospital from&#xD;
      August 2016 to August 2017 were randomly divided into selective anticoagulation group (SAG)&#xD;
      and conventional anticoagulation group (CAG). SAG used anticoagulant when TEG indicated&#xD;
      hypercoagulability while CAP used anticoagulant until one month after surgery regularly. Data&#xD;
      including patients' basic information, postoperative complications, perioperative clotting&#xD;
      index, intraoperative blood loss, perioperative TEG, volume of drainage, and blood&#xD;
      transfusion were evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Measured by ultrasound,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Measured by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>5 days after surgery</time_frame>
    <description>Measured by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Measured by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Measured by ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Incidence of Deep Vein Thrombosis</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Measured by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>5 days after surgery</time_frame>
    <description>Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>Number of Hemoglobin Measured by Blood Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Number of Hemoglobin Measured by Blood Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Number of Hemoglobin Measured by Blood Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>5 days after surgery</time_frame>
    <description>Number of Hemoglobin Measured by Blood Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Blood Cell</measure>
    <time_frame>1 day before surgery</time_frame>
    <description>Number of Red Blood Cell Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Blood Cell</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Number of Red Blood Cell Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Blood Cell</measure>
    <time_frame>3 days after surgery</time_frame>
    <description>Number of Red Blood Cell Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red Blood Cell</measure>
    <time_frame>5 days after surgery</time_frame>
    <description>Number of Red Blood Cell Measured by Complete Blood Count</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Transfusion</measure>
    <time_frame>During Hospitalization</time_frame>
    <description>Volume of Blood Transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfusion Rate</measure>
    <time_frame>During Hospitalization</time_frame>
    <description>Number of patients who receive transfusion divided by total number of patients in the group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial Infection</measure>
    <time_frame>During Hospitalization</time_frame>
    <description>Number of patients who suffer superficial infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial Infection</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Number of patients who suffer superficial infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial Infection</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Number of patients who suffer superficial infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Superficial Infection</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Number of patients who suffer superficial infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep Infection</measure>
    <time_frame>During Hospitalization</time_frame>
    <description>Number of patients who suffer deep infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep Infection</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Number of patients who suffer deep infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep Infection</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Number of patients who suffer deep infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deep Infection</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Number of patients who suffer deep infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ecchymosis incidence Rate</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Number of patients who suffer ecchymosis divided by total number of patients in the group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Venous Thrombosis, Deep</condition>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>selective anticoagulation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Selective anticoagulation group used anticoagulant when thromboelastogram（TEG） indicated hypercoagulability.&#xD;
TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery.&#xD;
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional anticoagulation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely.&#xD;
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>selective anticoagulation</intervention_name>
    <description>Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.</description>
    <arm_group_label>conventional anticoagulation group</arm_group_label>
    <arm_group_label>selective anticoagulation group</arm_group_label>
    <other_name>Thromboelastography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  over 18 years of age,&#xD;
&#xD;
          -  ASA Ⅰ-Ⅱ grade,&#xD;
&#xD;
          -  BMI &lt;40Kg / M ^ 2&#xD;
&#xD;
          -  Underwent total knee arthroplasty/ total hip arthroplasty in Guangdong General&#xD;
             Hospital&#xD;
&#xD;
          -  consent to enroll in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of VTE, preoperative infection, preoperative coagulation&#xD;
&#xD;
          -  liver and kidney function existed clinically abnormalities&#xD;
&#xD;
          -  history of tumor&#xD;
&#xD;
          -  history of vascular surgery&#xD;
&#xD;
          -  heart infarction or cerebral infarction within 6 months&#xD;
&#xD;
          -  history of lower extremity surgery within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</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>Thrombosis</mesh_term>
    <mesh_term>Thromboembolism</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT03804697
org study id: 2016-46
nct id: NCT03804697
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Asian populations have a lower rate of high-risk gene mutations of venous thrombosis, which
      means a reasonable perioperative anticoagulant management after hip or knee arthroplasty for
      Caucasian populations may be too excessive for Asians. So, individual patient risk
      assessment, rather than a "blanket policy", is considered the best thromboembolism
      prophylaxis for Asians.The purpose of this study was to evaluate the effectiveness and safety
      of selective thromboembolism prophylaxis compared with conventional thromboembolism
      prophylaxis by risk stratification with thromboelastography (TEG) after joint arthroplasty
      for Asian populations.
Asian patients who underwent hip or knee arthroplasty in Guangdong General Hospital from
      August 2016 to August 2017 were randomly divided into selective anticoagulation group (SAG)
      and conventional anticoagulation group (CAG). SAG used anticoagulant when TEG indicated
      hypercoagulability while CAP used anticoagulant until one month after surgery regularly. Data
      including patients' basic information, postoperative complications, perioperative clotting
      index, intraoperative blood loss, perioperative TEG, volume of drainage, and blood
      transfusion were evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The Incidence of Deep Vein Thrombosis
time frame: 1 day after surgery
description: Measured by ultrasound,
measure: The Incidence of Deep Vein Thrombosis
time frame: 3 days after surgery
description: Measured by ultrasound
measure: The Incidence of Deep Vein Thrombosis
time frame: 5 days after surgery
description: Measured by ultrasound
measure: The Incidence of Deep Vein Thrombosis
time frame: 1 month after surgery
description: Measured by ultrasound
measure: The Incidence of Deep Vein Thrombosis
time frame: 3 months after surgery
description: Measured by ultrasound
measure: The Incidence of Deep Vein Thrombosis
time frame: 6 months after surgery
description: Measured by ultrasound
measure: Hematocrit
time frame: 1 day before surgery
description: Measured by Complete Blood Count
measure: Hematocrit
time frame: 1 day after surgery
description: Measured by Complete Blood Count
measure: Hematocrit
time frame: 3 days after surgery
description: Measured by Complete Blood Count
measure: Hematocrit
time frame: 5 days after surgery
description: Measured by Complete Blood Count
measure: Hemoglobin
time frame: 1 day before surgery
description: Number of Hemoglobin Measured by Blood Test
measure: Hemoglobin
time frame: 1 day after surgery
description: Number of Hemoglobin Measured by Blood Test
measure: Hemoglobin
time frame: 3 days after surgery
description: Number of Hemoglobin Measured by Blood Test
measure: Hemoglobin
time frame: 5 days after surgery
description: Number of Hemoglobin Measured by Blood Test
measure: Red Blood Cell
time frame: 1 day before surgery
description: Number of Red Blood Cell Measured by Complete Blood Count
measure: Red Blood Cell
time frame: 1 day after surgery
description: Number of Red Blood Cell Measured by Complete Blood Count
measure: Red Blood Cell
time frame: 3 days after surgery
description: Number of Red Blood Cell Measured by Complete Blood Count
measure: Red Blood Cell
time frame: 5 days after surgery
description: Number of Red Blood Cell Measured by Complete Blood Count
measure: Volume of Transfusion
time frame: During Hospitalization
description: Volume of Blood Transfusion
measure: Transfusion Rate
time frame: During Hospitalization
description: Number of patients who receive transfusion divided by total number of patients in the group
measure: Superficial Infection
time frame: During Hospitalization
description: Number of patients who suffer superficial infection
measure: Superficial Infection
time frame: 1 month after surgery
description: Number of patients who suffer superficial infection
measure: Superficial Infection
time frame: 3 months after surgery
description: Number of patients who suffer superficial infection
measure: Superficial Infection
time frame: 6 months after surgery
description: Number of patients who suffer superficial infection
measure: Deep Infection
time frame: During Hospitalization
description: Number of patients who suffer deep infection
measure: Deep Infection
time frame: 1 month after surgery
description: Number of patients who suffer deep infection
measure: Deep Infection
time frame: 3 months after surgery
description: Number of patients who suffer deep infection
measure: Deep Infection
time frame: 6 months after surgery
description: Number of patients who suffer deep infection
measure: Ecchymosis incidence Rate
time frame: 1 month after surgery
description: Number of patients who suffer ecchymosis divided by total number of patients in the group
arm group label: selective anticoagulation group
arm group type: Experimental
description: Selective anticoagulation group used anticoagulant when thromboelastogram（TEG） indicated hypercoagulability.
TEG was performed 1 day before the surgery, 1 day after the surgery, 3 days after the surgery, and 5 days after the surgery.
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
arm group label: conventional anticoagulation group
arm group type: Active Comparator
description: The Intervention for conventional anticoagulation group was using anticoagulant until one month after surgery routinely.
The dosage regimen of anticoagulant was hypodermic injection 0.4 ml low molecular weight heparin per day for 5 days and oral administration of 10 mg Rivaroxaban until one month after the surgery.
intervention type: Drug
intervention name: selective anticoagulation
description: Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.
arm group label: conventional anticoagulation group
arm group label: selective anticoagulation group
other name: Thromboelastography
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Thromboembolism
mesh term: Venous Thrombosis