<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/NCT03011866</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-000391</org_study_id>
    <nct_id>NCT03011866</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries</brief_title>
  <acronym>TARGETS</acronym>
  <official_title>Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multilevel decompression and bone graft fusion is a most effective measure for treating&#xD;
      degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large&#xD;
      amount of perioperative blood loss and high demand for homologous blood transfusion.&#xD;
      Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in&#xD;
      various kinds of surgeries. However, high quality evidence of its efficacy and safety is&#xD;
      still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of&#xD;
      thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the&#xD;
      optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the&#xD;
      non-inferiority of topical TXA application to its intravenous use in multilevel decompression&#xD;
      and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head&#xD;
      comparison study design will be adopted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <primary_completion_date type="Anticipated">December 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perioperative Total blood loss (TBL)</measure>
    <time_frame>Since operation initiation till postoperative day 3 (POD3)</time_frame>
    <description>TBL= PBV*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visible intraoperative blood loss</measure>
    <time_frame>Since operation initiation till operation completion, an average of 120min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visible postoperative blood loss within 24hrs</measure>
    <time_frame>0- 24hrs postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visible postoperative blood loss within 48hrs</measure>
    <time_frame>0- 48hrs postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Combined visible perioperative blood loss</measure>
    <time_frame>Since operation initiation till postoperative 48hrs</time_frame>
    <description>Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total postoperative blood loss</measure>
    <time_frame>0- 48hrs postoperatively</time_frame>
    <description>Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hidden blood loss (HBL)</measure>
    <time_frame>48hrs postoperatively</time_frame>
    <description>HBL=TBL- combined visible perioperative blood loss</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative prothrombin time(PT)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative activated partial thromboplastin time(APTT)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative fibrinogen level(Fbg)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative international normalized ratio(INR)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative R time</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative K time</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative maximum amplitude (MA)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative lysis after 30 minutes(LY 30)</measure>
    <time_frame>Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hemoglobin nadir</measure>
    <time_frame>Since operation completion till postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative transfusion rates</measure>
    <time_frame>Since operation initiation till postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative transfusion amounts</measure>
    <time_frame>Since operation initiation till postoperative 48hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>A single inpatient duration since the day of admission till the day of discharge, an average of 1 week</time_frame>
    <description>Length of hospital stay is calculated by subtracting day of admission from day of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event rates</measure>
    <time_frame>Since operation initiation till postoperative 48hrs</time_frame>
    <description>Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Spinal Stenosis</condition>
  <condition>Intervertebral Disc Displacement</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation.&#xD;
Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation.&#xD;
Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Wound topically irrigated with 500mg TXA</intervention_name>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1mg/kg/hr TXA intravenous infusion till the last suture</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists(ASA)classification of physical status I-II.&#xD;
&#xD;
          -  Aged over 50yrs.&#xD;
&#xD;
          -  Patients suffering from spinal stenosis or intervertebral disc displacement and&#xD;
             require multilevel decompression and bone graft fusion surgeries.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA III-IV.&#xD;
&#xD;
          -  Age≤ 50yrs.&#xD;
&#xD;
          -  History of chronic renal dysfunction (preoperative blood creatinine&gt; 120mmol/L), liver&#xD;
             dysfunction (preoperative blood aspartate or alanine aminotransferase&gt; 50 units/L) or&#xD;
             history of coronary artery disease with stent placement.&#xD;
&#xD;
          -  Abnormal preoperative coagulation profile (preoperative prothrombin time elongation&gt;&#xD;
             3s, activated partial thromboplastin time elongation&gt; 10s, platelet counts&lt; 100*10^9/L&#xD;
             or &gt;400*10^9/L, or INR&gt; 1.4).&#xD;
&#xD;
          -  Pre-existing anemia (male&lt; 12g/dL, female&lt;11g/dL).&#xD;
&#xD;
          -  Long-term medications of aspirin and/or other anticoagulants.&#xD;
&#xD;
          -  Patients known as allergic to TXA.&#xD;
&#xD;
          -  Patients who have religious and/or other beliefs limiting blood transfusion.&#xD;
&#xD;
          -  Dura mater laceration and/or unexpected massive bleeding during operation.&#xD;
&#xD;
          -  Cell saver application during operation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Qianyu Zhuang, M.D.</last_name>
    <phone>86-13552869326</phone>
    <email>zhuangqianyu@pumch.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qianyu Zhuang, M.D.</last_name>
    <phone>86-13552869326</phone>
    <email>zhuangqianyu@126.com</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Shugang Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Stenosis</mesh_term>
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
    <mesh_term>Hemorrhage</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/NCT03011866
org study id: PUMCH-000391
nct id: NCT03011866
lead sponsor: 
has dmc: Yes
Multilevel decompression and bone graft fusion is a most effective measure for treating
      degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large
      amount of perioperative blood loss and high demand for homologous blood transfusion.
      Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in
      various kinds of surgeries. However, high quality evidence of its efficacy and safety is
      still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of
      thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the
      optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the
      non-inferiority of topical TXA application to its intravenous use in multilevel decompression
      and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head
      comparison study design will be adopted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Perioperative Total blood loss (TBL)
time frame: Since operation initiation till postoperative day 3 (POD3)
description: TBL= PBV*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1* height^3(m)+ k2* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)
measure: Visible intraoperative blood loss
time frame: Since operation initiation till operation completion, an average of 120min
measure: Visible postoperative blood loss within 24hrs
time frame: 0- 24hrs postoperatively
measure: Visible postoperative blood loss within 48hrs
time frame: 0- 48hrs postoperatively
measure: Combined visible perioperative blood loss
time frame: Since operation initiation till postoperative 48hrs
description: Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs
measure: Total postoperative blood loss
time frame: 0- 48hrs postoperatively
description: Total postoperative blood loss= drainage day1(ml)* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)* drainage Hct day2(%)/blood Hct day2(%)
measure: Postoperative hidden blood loss (HBL)
time frame: 48hrs postoperatively
description: HBL=TBL- combined visible perioperative blood loss
measure: Postoperative prothrombin time(PT)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative activated partial thromboplastin time(APTT)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative fibrinogen level(Fbg)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative international normalized ratio(INR)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative R time
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative K time
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative maximum amplitude (MA)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative lysis after 30 minutes(LY 30)
time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative hemoglobin nadir
time frame: Since operation completion till postoperative 48hrs
measure: Perioperative transfusion rates
time frame: Since operation initiation till postoperative 48hrs
measure: Perioperative transfusion amounts
time frame: Since operation initiation till postoperative 48hrs
measure: Length of hospital stay
time frame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week
description: Length of hospital stay is calculated by subtracting day of admission from day of discharge.
measure: Adverse event rates
time frame: Since operation initiation till postoperative 48hrs
description: Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.
arm group label: Experimental
arm group type: Experimental
description: Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
arm group label: Control
arm group type: Other
description: Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation.
Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.
intervention type: Drug
intervention name: Wound topically irrigated with 500mg TXA
arm group label: Experimental
intervention type: Drug
intervention name: 1mg/kg/hr TXA intravenous infusion till the last suture
arm group label: Control
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Qianyu Zhuang, M.D.
phone: 86-13552869326
email: zhuangqianyu@pumch.cn
last name: Qianyu Zhuang, M.D.
phone: 86-13552869326
email: zhuangqianyu@126.com
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Shugang Li
investigator title: Professor
mesh term: Spinal Stenosis
mesh term: Intervertebral Disc Displacement
mesh term: Hemorrhage