<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/NCT03037515</url>
  </required_header>
  <id_info>
    <org_study_id>10608</org_study_id>
    <nct_id>NCT03037515</nct_id>
  </id_info>
  <brief_title>Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery</brief_title>
  <official_title>A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Lumbar Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to compare the effectiveness of two different but well&#xD;
      accepted routes of administration of tranexamic acid in order to reduce blood loss and need&#xD;
      for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks&#xD;
      to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing&#xD;
      blood loss and need for transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spine surgery is associated with large amount of perioperative blood loss. Factors&#xD;
      influencing blood loss include surgical technique, operative time, number of vertebral levels&#xD;
      arthrodesed, and others. Significant blood loss is associated with complications such as&#xD;
      hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of&#xD;
      infection, blood incompatibility, and allergic reactions. Due to the significant risks and&#xD;
      complications associated with blood loss and allogenic transfusions, efforts to identify safe&#xD;
      and effective ways of lowering blood loss during spine surgery are crucial. Many methods have&#xD;
      been utilized to reduce allogenic blood transfusions, such as autologous blood predonation,&#xD;
      antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and&#xD;
      others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA)&#xD;
      and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac,&#xD;
      gynecological, urologic and total joint replacement surgeries. There have been many published&#xD;
      studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While&#xD;
      aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and&#xD;
      EACA have not been shown to cause any substantial morbidity or to increase rate of&#xD;
      thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss&#xD;
      and transfusions in patients undergoing spine surgery, no studies in the literature have&#xD;
      investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The&#xD;
      investigators believe that PO TXA will be just as efficacious and more cost-effective in&#xD;
      reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.&#xD;
&#xD;
      The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and&#xD;
      need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood&#xD;
      loss and need for transfusion, significant cost savings can be achieved for the patient and&#xD;
      the health care system in general.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 15, 2017</start_date>
  <completion_date type="Anticipated">November 16, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2017</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intra-operative blood loss between the two groups</measure>
    <time_frame>Day of surgery to 1 day after surgery, up to 7 days</time_frame>
    <description>For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative drop in hemoglobin between the two groups</measure>
    <time_frame>1 day after surgery until patient is discharged, up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative blood loss between the two groups</measure>
    <time_frame>1 day after surgery until patient is discharged, up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of units transfused between the two groups</measure>
    <time_frame>1 day after surgery until patient is discharged, up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative drain output between the two groups</measure>
    <time_frame>1 day after surgery until patient is discharged, up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of thromboembolic events between the two groups</measure>
    <time_frame>1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Blood Loss Anemia</condition>
  <arm_group>
    <arm_group_label>Intravenous Tranexamic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral Tranexamic Acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.</description>
    <arm_group_label>Intravenous Tranexamic Acid</arm_group_label>
    <arm_group_label>Oral Tranexamic Acid</arm_group_label>
    <other_name>Lysteda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients over age 18 and scheduled for open lumbar spine surgery (primary or&#xD;
             revision)&#xD;
&#xD;
          -  Must be able to swallow tablets&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known allergy to TXA&#xD;
&#xD;
          -  History of renal failure or kidney transplant&#xD;
&#xD;
          -  History of arterial thromboembolic event (eg. myocardial infarction, stroke) within&#xD;
             the past year&#xD;
&#xD;
          -  Placement of an arterial stent within the past year&#xD;
&#xD;
          -  History of blood clots (DVT, PE) within the past year&#xD;
&#xD;
          -  Refusal to receive blood products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Charles C Yu, MD</last_name>
    <phone>314-614-3536</phone>
    <email>cyu1@hfhs.org</email>
  </overall_contact>
  <reference>
    <citation>Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.</citation>
    <PMID>21936146</PMID>
  </reference>
  <reference>
    <citation>Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.</citation>
    <PMID>12697586</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Stephen Bartol</investigator_full_name>
    <investigator_title>Orthopaedic Spine Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</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>
  <!-- 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/NCT03037515
org study id: 10608
nct id: NCT03037515
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this project is to compare the effectiveness of two different but well
      accepted routes of administration of tranexamic acid in order to reduce blood loss and need
      for transfusion in patients undergoing lumbar spine surgery. Specifically, this study seeks
      to identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing
      blood loss and need for transfusion.
Spine surgery is associated with large amount of perioperative blood loss. Factors
      influencing blood loss include surgical technique, operative time, number of vertebral levels
      arthrodesed, and others. Significant blood loss is associated with complications such as
      hypotension, end organ damage, or coagulopathy. Blood transfusions can increase risks of
      infection, blood incompatibility, and allergic reactions. Due to the significant risks and
      complications associated with blood loss and allogenic transfusions, efforts to identify safe
      and effective ways of lowering blood loss during spine surgery are crucial. Many methods have
      been utilized to reduce allogenic blood transfusions, such as autologous blood predonation,
      antifibrinolytic drugs, acute normovolemic hemodilution, intraoperative blood salvage, and
      others. Furthermore, the administration of antifibrinolytics, such as tranexamic acid (TXA)
      and epsilon-aminocaproic acid (EACA), has been shown to reduce bleeding in cardiac,
      gynecological, urologic and total joint replacement surgeries. There have been many published
      studies investigating various antifibrinolytic agents such as TXA, EACA, and aprotinin. While
      aprotinin was shown to increase mortality rate in patients following cardiac surgery, TXA and
      EACA have not been shown to cause any substantial morbidity or to increase rate of
      thromboembolic events. Although IV TXA has been shown to be effective in reducing blood loss
      and transfusions in patients undergoing spine surgery, no studies in the literature have
      investigated the efficacy of PO TXA in decreasing blood loss and transfusions. The
      investigators believe that PO TXA will be just as efficacious and more cost-effective in
      reducing blood loss and transfusion needs in patients undergoing lumbar spine surgery.

      The ultimate goal is identifying the most cost-effective protocol to decrease blood loss and
      need for transfusion. If oral TXA is found to be as efficacious as IV TXA in reducing blood
      loss and need for transfusion, significant cost savings can be achieved for the patient and
      the health care system in general.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Intra-operative blood loss between the two groups
time frame: Day of surgery to 1 day after surgery, up to 7 days
description: For males: BV = 0.3669*(Height in meters)^3 + 0.03219*(Weight in kilograms) + 0.6041 For females: BV = 0.3561*(Height in meters)^3 + 0.03308*(Weight in kilograms) + 0.1833 Hbloss = BV*(Hbi-Hbe )*0.001 + Hbt Blood loss = 1000*(Hbloss/Hbi) Hbloss = Hemoglobin loss; BV = Blood Volume; Hbi = initial Hgb; Hbe = ending Hgb; Hbt = transfused Hgb = about 52g (SD 5.4g) per 1u pRBC (320mL)
measure: Post-operative drop in hemoglobin between the two groups
time frame: 1 day after surgery until patient is discharged, up to 7 days
measure: Post-operative blood loss between the two groups
time frame: 1 day after surgery until patient is discharged, up to 7 days
measure: Number of units transfused between the two groups
time frame: 1 day after surgery until patient is discharged, up to 7 days
measure: Post-operative drain output between the two groups
time frame: 1 day after surgery until patient is discharged, up to 7 days
measure: Incidence of thromboembolic events between the two groups
time frame: 1 day after surgery until patient returns for first postoperative visit (through study completion, an average of 4 weeks after surgery)
arm group label: Intravenous Tranexamic Acid
arm group type: Active Comparator
description: The IV TXA group will receive the standard dosing for our institution of 1 g TXA (diluted in 100 mL normal saline) given as an IV bolus immediately before incision and another 1 g TXA given before closure.
arm group label: Oral Tranexamic Acid
arm group type: Active Comparator
description: The oral TXA group will receive 1950 mg TXA (3 tablets of 650 mg) approximately 2 hours before incision.
intervention type: Drug
intervention name: Tranexamic Acid
description: To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
arm group label: Intravenous Tranexamic Acid
arm group label: Oral Tranexamic Acid
other name: Lysteda
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Charles C Yu, MD
phone: 314-614-3536
email: cyu1@hfhs.org
citation: Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PMID: 21936146
citation: Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
PMID: 12697586
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Stephen Bartol
investigator title: Orthopaedic Spine Surgeon
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Tranexamic Acid