xml: <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/NCT06023212</url>
    </required_header>
    <id_info>
      <org_study_id>2022_LHY</org_study_id>
      <nct_id>NCT06023212</nct_id>
    </id_info>
    <brief_title>Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumors</brief_title>
    <official_title>Tranexamic Acid Use for Bleeding Prevention in the Surgical Treatment of Metastatic Spinal Tumor: a Single Center, Randomized Controlled Trial to Assess the Efficacy of Tranexamic Acid for Hemostasis</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>
        Massive blood loss occurs in metastatic spinal tumor resection and may cause severe&#xD;
        complications. The objective of this study is to investigate whether the use of tranexamic&#xD;
        acid will reduce perioperative and postoperative bleeding when compared to those without use&#xD;
        of tranexamic acid.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <phase>Phase 1/Phase 2</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>total blood loss</measure>
      <time_frame>measured 3 days postoperatively</time_frame>
      <description>the loss of total blood volume caused by various operations (mainly during surgical operations) throughout the entire treatment process.&#xD;
  Total blood volume = preoperative blood volume *（preoperative hematocrit - hematocrit 3 days postoperatively）</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intraoperative blood loss</measure>
      <time_frame>1 day (measured once after surgery)</time_frame>
      <description>Refers to the total blood loss of a patient experienced during operation from skin incision to wound suture.&#xD;
  Intraoperative blood loss = intraoperative drainage volume - intraoperative flushing volume + blood loss estimation using gauze (calculated as 10 cm × 10 cm gauze absorbs 10 ml)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>allogeneic transfusion blood volume</measure>
      <time_frame>1 day (measured once during surgery)</time_frame>
      <description>amount of allogeneic transfusion blood volume needed during operation</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Metastasis Spinal Tumor</condition>
    <arm_group>
      <arm_group_label>tranexamic acid group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>injection of 2 bottles of tranexamic acid (1g/bottle) before making incision; tranexamic acid soaked gauze applied to the wound before closing the wound; Intravenous injection of tranexamic acid 3 times (every 8 hours）within 24 hours after operation；</description>
    </arm_group>
    <arm_group>
      <arm_group_label>SPSS group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>injection of 2 bottles of stroke-physiological saline solution（SPSS）before making incision; SPSS soaked gauze applied to the wound before closing the wound; Intravenous injection of SPSS 3 times (every 8 hours）within 24 hours after operation；</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tranexamic Acid</intervention_name>
      <description>IV drip of 2 bottles of tranexamic acid (2g) before making incision during surgery；&#xD;
  1g tranexamic acid soaked gauze applied to the wound for 5 minintes before suture； patients were administered IV drip of tranexamic acid 3 times (every 8 hours)within 24 hours after surgery.</description>
      <arm_group_label>tranexamic acid group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>stroke-physiological saline solution (SPSS)</intervention_name>
      <description>IV drip of 2 bottles of saline before making incision during surgery； saline soaked gauze applied to the wound for 5 minintes before suture； patients were administered IV drip of saline 3 times (every 8 hours)within 24 hours after surgery.</description>
      <arm_group_label>SPSS group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed as metastatic carcinoma of the thoracolumbar spine&#xD;
  &#xD;
            -  solitary neoplasm involve only one segment of spine&#xD;
  &#xD;
            -  patients underwent separation surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  coagulation function was abnormal preoperatively&#xD;
  &#xD;
            -  patients are allergic to tranexamic acid&#xD;
  &#xD;
            -  neoplasm involve more than one segment of spine&#xD;
  &#xD;
            -  patients with rich blood supply who need embolization&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hengyuan Li, MD</last_name>
      <phone>13616519278</phone>
      <email>hengyuanxiang007@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>the Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>311200</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hengyuan Li, MD</last_name>
        <phone>13616519278</phone>
        <email>hengyuanxiang007@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Tranexamic Acid</keyword>
    <keyword>blood loss</keyword>
    <keyword>seperation surgery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Cord Neoplasms</mesh_term>
      <mesh_term>Spinal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tranexamic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023212
  org study id: 2022_LHY
  nct id: NCT06023212
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Massive blood loss occurs in metastatic spinal tumor resection and may cause severe
        complications. The objective of this study is to investigate whether the use of tranexamic
        acid will reduce perioperative and postoperative bleeding when compared to those without use
        of tranexamic acid.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: total blood loss
  time frame: measured 3 days postoperatively
  description: the loss of total blood volume caused by various operations (mainly during surgical operations) throughout the entire treatment process.
  Total blood volume = preoperative blood volume *（preoperative hematocrit - hematocrit 3 days postoperatively）
  measure: Intraoperative blood loss
  time frame: 1 day (measured once after surgery)
  description: Refers to the total blood loss of a patient experienced during operation from skin incision to wound suture.
  Intraoperative blood loss = intraoperative drainage volume - intraoperative flushing volume + blood loss estimation using gauze (calculated as 10 cm × 10 cm gauze absorbs 10 ml)
  measure: allogeneic transfusion blood volume
  time frame: 1 day (measured once during surgery)
  description: amount of allogeneic transfusion blood volume needed during operation
  arm group label: tranexamic acid group
  arm group type: Experimental
  description: injection of 2 bottles of tranexamic acid (1g/bottle) before making incision; tranexamic acid soaked gauze applied to the wound before closing the wound; Intravenous injection of tranexamic acid 3 times (every 8 hours）within 24 hours after operation；
  arm group label: SPSS group
  arm group type: Placebo Comparator
  description: injection of 2 bottles of stroke-physiological saline solution（SPSS）before making incision; SPSS soaked gauze applied to the wound before closing the wound; Intravenous injection of SPSS 3 times (every 8 hours）within 24 hours after operation；
  intervention type: Drug
  intervention name: Tranexamic Acid
  description: IV drip of 2 bottles of tranexamic acid (2g) before making incision during surgery；
  1g tranexamic acid soaked gauze applied to the wound for 5 minintes before suture； patients were administered IV drip of tranexamic acid 3 times (every 8 hours)within 24 hours after surgery.
  arm group label: tranexamic acid group
  intervention type: Drug
  intervention name: stroke-physiological saline solution (SPSS)
  description: IV drip of 2 bottles of saline before making incision during surgery； saline soaked gauze applied to the wound for 5 minintes before suture； patients were administered IV drip of saline 3 times (every 8 hours)within 24 hours after surgery.
  arm group label: SPSS group
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hengyuan Li, MD
  phone: 13616519278
  email: hengyuanxiang007@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Spinal Cord Neoplasms
  mesh term: Spinal Neoplasms
  mesh term: Tranexamic Acid
  sharing ipd: Undecided