<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/NCT04410042</url>
  </required_header>
  <id_info>
    <org_study_id>TXAKIDS</org_study_id>
    <secondary_id>NCI-2020-02984</secondary_id>
    <nct_id>NCT04410042</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid Use to Reduce Blood Transfusion in Pediatric Cancer Patients Undergoing Limb Salvage Procedure</brief_title>
  <official_title>Tranexamic Acid (TXA) to Reduce Volume Of Blood Transfused In Pediatric And Young Adult Cancer Patients Undergoing Limb Salvage Procedure Of A Lower Extremity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to&#xD;
      decrease blood loss and transfusion requirements in pediatric and young adult cancer patients&#xD;
      undergoing a limb salvage procedure that frequently requires perioperative or post-operative&#xD;
      transfusions of blood products.&#xD;
&#xD;
      Primary Objective&#xD;
&#xD;
        -  To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg)&#xD;
           for patients undergoing limb salvage procedures of the distal femur or proximal tibia&#xD;
           who are randomized to receive perioperative tranexamic acid (TXA) versus placebo.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        -  To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for&#xD;
           patients randomized to receive perioperative TXA versus placebo.&#xD;
&#xD;
        -  To evaluate differences in post-operative daily surgical drain output for patients&#xD;
           randomized to receive perioperative TXA versus placebo.&#xD;
&#xD;
        -  To evaluate changes in estimated blood loss (EBL) for patients randomized to receive&#xD;
           perioperative TXA versus placebo.&#xD;
&#xD;
        -  To evaluate the association between the intra-or post-operatively transfused blood&#xD;
           volume and estimated blood loss (EBL) for patients randomized to receive perioperative&#xD;
           TXA and placebo, respectively.&#xD;
&#xD;
      Exploratory Objectives&#xD;
&#xD;
        -  To evaluate differences in functional outcomes post-operatively for patients randomized&#xD;
           to receive perioperative TXA versus placebo.&#xD;
&#xD;
        -  To explore if significant correlations are observed between parameters reported with&#xD;
           rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric&#xD;
           and young adult patients undergoing limb salvage procedure who are randomized to&#xD;
           perioperative TXA versus placebo.&#xD;
&#xD;
        -  To evaluate differences in the prevalence and management of wound complications such as&#xD;
           superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post-&#xD;
           operative hematomas, or any other clinically significant wound complication between&#xD;
           patients randomized to receive perioperative TXA versus placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible participants undergoing limb salvage procedures will be randomized to receive either&#xD;
      tranexamic acid (TXA) or placebo peri-operatively.&#xD;
&#xD;
      The initial dose of tranexamic acid/placebo will be given at the initiation of surgical&#xD;
      preparation. The second dose will be given 6 hours after the first dose (either&#xD;
      intraoperatively or post-operatively). All doses will be given intravenously. Doses will be&#xD;
      double blinded and randomized for each surgical procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 29, 2021</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>To allow for the study team and participants to remain blinded to the treatment assignment, the study drug will be labeled as Tranexamic Acid/Placebo (TXAKIDS) followed by applicable dose and administration instructions.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in intra-operatively transfused blood volume (mL/kg)</measure>
    <time_frame>During surgery</time_frame>
    <description>The intra-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in post-operatively transfused blood volume (mL/kg)</measure>
    <time_frame>After surgery; approximately 1-7 days</time_frame>
    <description>The post-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in platelet level</measure>
    <time_frame>Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)</time_frame>
    <description>Summary statistics will be provided for the changes in platelet level from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hemoglobin level (g/dL)</measure>
    <time_frame>Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)</time_frame>
    <description>Summary statistics will be provided for the decline in hemoglobin from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative daily surgical drain output</measure>
    <time_frame>After surgery for the duration until the drain is pulled (approximately 1-7 days)</time_frame>
    <description>Summary statistics will be provided for postoperative daily surgical drain output (in milliliters per 24 hour period for the duration of the drain) for each group. The group difference will be compared using two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in estimated blood loss (EBL)</measure>
    <time_frame>During surgery until the conclusion of surgery</time_frame>
    <description>The EBL for pre-op to post-op level, for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The EBL of the two groups (TXA vs. Placebo) will be evaluated using a two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-or post-operatively transfused blood volume</measure>
    <time_frame>During and after surgery (approximately 1-7 days)</time_frame>
    <description>Regression model will be used to access the correlation between the log transformed intra-or post-operatively transfused blood volume and EBL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Cancer of the Bone</condition>
  <condition>Limb Salvage</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At initiation of surgical preparation, participants randomized to the active treatment arm will receive tranexamic acid 10 mg/kg (max 1 g), given via syringe pump programmed to infuse over 15 minutes. If no unacceptable toxicities occur, a second dose of tranexamic acid IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>At initiation of surgical preparation, participants randomized to the placebo treatment arm will receive 0.9% sodium chloride (salt water). It will be matched in appearance, volume, and administration to the active treatment arm with tranexamic acid. If no unacceptable toxicities occur, a second dose of placebo IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Tranexamic Acid</arm_group_label>
    <other_name>Cyklokapron®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0.9% sodium chloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Salt water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant undergoing limb salvage procedure of malignant bone tumor of the distal&#xD;
             femur or proximal tibia, which typically requires blood transfusions.&#xD;
&#xD;
          -  Patient under the age of 25&#xD;
&#xD;
          -  Adequate bone marrow function defined as:&#xD;
&#xD;
               -  Upward trending peripheral absolute neutrophil count (ANC)&#xD;
&#xD;
               -  Platelet count ≥ 100,000/mm^3 (transfusion independent defined as no platelets&#xD;
                  required for 4 days)&#xD;
&#xD;
               -  Hemoglobin ≥ 8.0 g/dL&#xD;
&#xD;
               -  No RBC transfusion within 24 hours&#xD;
&#xD;
          -  Adequate renal function defined as:&#xD;
&#xD;
               -  Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73m^2 OR&#xD;
&#xD;
               -  Maximum serum creatinine based on age/gender as follows: Age 1 day to &lt; 1 years:&#xD;
                  maximum serum creatinine (mg/dL) 0.6 for males and 0.5 for females; Age 1 to &lt; 2&#xD;
                  years: maximum serum creatinine (mg/dL) 0.6 for males and 0.6 for females; Age 2&#xD;
                  to &lt; 6 years: maximum serum creatinine (mg/dL) 0.8 for males and 0.8 for females;&#xD;
                  Age 6 to &lt; 10 years: maximum serum creatinine (mg/dL) 1.0 for males and 1.0 for&#xD;
                  females; Age 10 to &lt; 13 years: maximum serum creatinine (mg/dL) 1.2 for males and&#xD;
                  1.2 for females; Age 13 to &lt; 16 years: maximum serum creatinine (mg/dL) 1.5 for&#xD;
                  males and 1.4 for females; Age ≥ 16 years: maximum serum creatinine (mg/dL) 1.7&#xD;
                  for males and 1.4 for females&#xD;
&#xD;
          -  Adequate liver function defined as:&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5x the institutional upper limit of normal (IULN) for age&#xD;
&#xD;
               -  ALT (SGPT) and AST (SGOT) ≤ 2.5x IULN for age (or &lt;5x IULN for patients with&#xD;
                  documented disease involving the liver or 10x IULN for patients receiving HDMTX)&#xD;
&#xD;
               -  Serum albumin &gt; 2 g/dL&#xD;
&#xD;
          -  Adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5&#xD;
&#xD;
          -  Female participants of child-bearing potential (&gt;10 years old) must have a negative&#xD;
             serum or urine pregnancy test within 72 hours of sedation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants whose limb salvage procedure may require significant manipulation of&#xD;
             major blood vessels.&#xD;
&#xD;
          -  Participants with known bone marrow deficiency resulting in red blood cell deficiency&#xD;
             (e.g. Diamond-Blackfan anemia)&#xD;
&#xD;
          -  Participants receiving erythropoietin-stimulating agents (e.g. epoetin alfa)&#xD;
&#xD;
          -  Participants with active hemorrhagic cystitis (e.g. alkylator-induced) with gross&#xD;
             hematuria or &gt;50 RBCs per high powered field on urinalysis&#xD;
&#xD;
          -  Participants actively receiving all-trans retinoic acid (ATRA) or isotretinoin&#xD;
             (Accutane)&#xD;
&#xD;
          -  Participants with known allergies to antifibrinolytics&#xD;
&#xD;
          -  Participants with known hypercoagulopathies&#xD;
&#xD;
          -  Personal history of a thrombosis or active thrombus&#xD;
&#xD;
          -  Participants currently on anticoagulation medications (e.g. warfarin, enoxaparin)&#xD;
&#xD;
          -  Participants with a history of seizures. Patients with a history of febrile seizure&#xD;
             are eligible.&#xD;
&#xD;
          -  Persisting toxicity related to other systemic therapies (e.g. chemotherapy) which&#xD;
             constitutes an unacceptable safety risk based on the judgment of the PI and/or the&#xD;
             primary treating physician.&#xD;
&#xD;
          -  Female participants who are currently pregnant or actively breastfeeding.&#xD;
&#xD;
          -  Female participants who are currently receiving estrogen-based contraception therapy.&#xD;
&#xD;
          -  Inability or unwillingness of research participant or legal guardian/representative to&#xD;
             give written informed consent.&#xD;
&#xD;
          -  Participants enrolled in another clinical trial utilizing an IND/IDE experimental&#xD;
             therapy.&#xD;
&#xD;
          -  Participants with a history of CNS disease.&#xD;
&#xD;
          -  Participants with known bleeding disorder.&#xD;
&#xD;
          -  Participants with known platelet dysfunction.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D. Neel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael D. Neel, MD</last_name>
    <phone>866-278-5833</phone>
    <email>referralinfo@stjude.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael D. Neel, MD</last_name>
      <phone>866-278-5833</phone>
      <email>referralinfo@stjude.org</email>
    </contact>
    <investigator>
      <last_name>Michael D. Neel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>ClinicalTrials Open at St. Jude</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood Transfusion</keyword>
  <keyword>Cancer of the bone</keyword>
  <keyword>Distal femur</keyword>
  <keyword>Limb Salvage</keyword>
  <keyword>Malignant Bone Tumor</keyword>
  <keyword>Placebo</keyword>
  <keyword>Proximal tibia</keyword>
  <keyword>Randomized</keyword>
  <keyword>Tranexamic acid</keyword>
  <keyword>TXA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone 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>Yes</sharing_ipd>
    <ipd_description>Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Data will be made available at the time of article publication.</ipd_time_frame>
    <ipd_access_criteria>Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04410042
org study id: TXAKIDS
secondary id: NCI-2020-02984
nct id: NCT04410042
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized double-blind control trial evaluating the use Tranexamic acid (TXA) to
      decrease blood loss and transfusion requirements in pediatric and young adult cancer patients
      undergoing a limb salvage procedure that frequently requires perioperative or post-operative
      transfusions of blood products.

      Primary Objective

        -  To evaluate the difference in intra-or post-operatively transfused blood volume (mL/kg)
           for patients undergoing limb salvage procedures of the distal femur or proximal tibia
           who are randomized to receive perioperative tranexamic acid (TXA) versus placebo.

      Secondary Objectives

        -  To evaluate changes in platelets and in hemoglobin from pre-op to post-op level for
           patients randomized to receive perioperative TXA versus placebo.

        -  To evaluate differences in post-operative daily surgical drain output for patients
           randomized to receive perioperative TXA versus placebo.

        -  To evaluate changes in estimated blood loss (EBL) for patients randomized to receive
           perioperative TXA versus placebo.

        -  To evaluate the association between the intra-or post-operatively transfused blood
           volume and estimated blood loss (EBL) for patients randomized to receive perioperative
           TXA and placebo, respectively.

      Exploratory Objectives

        -  To evaluate differences in functional outcomes post-operatively for patients randomized
           to receive perioperative TXA versus placebo.

        -  To explore if significant correlations are observed between parameters reported with
           rotational thromboelastometry (ROTEM®) and EBL and transfusion requirements in pediatric
           and young adult patients undergoing limb salvage procedure who are randomized to
           perioperative TXA versus placebo.

        -  To evaluate differences in the prevalence and management of wound complications such as
           superficial or periprosthetic infections, wound dehiscence, contact dermatitis, post-
           operative hematomas, or any other clinically significant wound complication between
           patients randomized to receive perioperative TXA versus placebo.
Eligible participants undergoing limb salvage procedures will be randomized to receive either
      tranexamic acid (TXA) or placebo peri-operatively.

      The initial dose of tranexamic acid/placebo will be given at the initiation of surgical
      preparation. The second dose will be given 6 hours after the first dose (either
      intraoperatively or post-operatively). All doses will be given intravenously. Doses will be
      double blinded and randomized for each surgical procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
masking description: To allow for the study team and participants to remain blinded to the treatment assignment, the study drug will be labeled as Tranexamic Acid/Placebo (TXAKIDS) followed by applicable dose and administration instructions.
measure: Difference in intra-operatively transfused blood volume (mL/kg)
time frame: During surgery
description: The intra-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.
measure: Difference in post-operatively transfused blood volume (mL/kg)
time frame: After surgery; approximately 1-7 days
description: The post-operative volumes of transfused blood for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The blood volumes transfused per kilogram of body weight of the two groups (TXA vs. Placebo) will be evaluated using a two-sided student's t-test after log(1+x) transformation.
measure: Changes in platelet level
time frame: Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)
description: Summary statistics will be provided for the changes in platelet level from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
measure: Changes in hemoglobin level (g/dL)
time frame: Pre-operatively (no more than 7 days prior to start of therapy), daily while inpatient and post operatively (approximately 1 week post-op)
description: Summary statistics will be provided for the decline in hemoglobin from pre-op to post-op level, for both the TXA and placebo group. Two sample t-test or Wilcoxon rank sum test will be used to compare the differences between the two groups. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
measure: Post-operative daily surgical drain output
time frame: After surgery for the duration until the drain is pulled (approximately 1-7 days)
description: Summary statistics will be provided for postoperative daily surgical drain output (in milliliters per 24 hour period for the duration of the drain) for each group. The group difference will be compared using two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data. Multiple comparison correction might be used for p-values to address the multiple testing issues due to measurements at multiple time points.
measure: Changes in estimated blood loss (EBL)
time frame: During surgery until the conclusion of surgery
description: The EBL for pre-op to post-op level, for both the TXA treated group and placebo group will be estimated with a two-sided 95% confidence interval. The EBL of the two groups (TXA vs. Placebo) will be evaluated using a two-sample t-test or Wilcoxon rank sum test depending on the distribution of the observed data.
measure: Intra-or post-operatively transfused blood volume
time frame: During and after surgery (approximately 1-7 days)
description: Regression model will be used to access the correlation between the log transformed intra-or post-operatively transfused blood volume and EBL.
arm group label: Tranexamic Acid
arm group type: Experimental
description: At initiation of surgical preparation, participants randomized to the active treatment arm will receive tranexamic acid 10 mg/kg (max 1 g), given via syringe pump programmed to infuse over 15 minutes. If no unacceptable toxicities occur, a second dose of tranexamic acid IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).
arm group label: Placebo
arm group type: Placebo Comparator
description: At initiation of surgical preparation, participants randomized to the placebo treatment arm will receive 0.9% sodium chloride (salt water). It will be matched in appearance, volume, and administration to the active treatment arm with tranexamic acid. If no unacceptable toxicities occur, a second dose of placebo IV push over 5 to 15 minutes will be given 6 hours (with a window of +/- 30 minutes) after the first dose (either intra- or post-operatively).
intervention type: Drug
intervention name: Tranexamic Acid
description: Given IV
arm group label: Tranexamic Acid
other name: Cyklokapron®
intervention type: Other
intervention name: 0.9% sodium chloride
description: Given IV
arm group label: Placebo
other name: Salt water
criteria: 
gender: All
minimum age: N/A
maximum age: 24 Years
healthy volunteers: No
last name: Michael D. Neel, MD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
last name: Michael D. Neel, MD
phone: 866-278-5833
email: referralinfo@stjude.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: ClinicalTrials Open at St. Jude
responsible party type: Sponsor
mesh term: Bone Neoplasms
mesh term: Tranexamic Acid
sharing ipd: Yes
ipd description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Data will be made available at the time of article publication.
ipd access criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.