<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/NCT03823417</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00030426</org_study_id>
    <nct_id>NCT03823417</nct_id>
  </id_info>
  <brief_title>The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO</brief_title>
  <official_title>The Effectiveness Of Intravenous Tranexamic Acid (TXA) on Reducing Perioperative Blood Loss For Patients Undergoing Periacetabular Osteotomy (PAO): A Randomized Double Blind Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's 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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this research study the investigators want to learn more about how a medication called&#xD;
      tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO)&#xD;
      surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of&#xD;
      bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood&#xD;
      clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively&#xD;
      prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.&#xD;
&#xD;
      As PAO surgery has been associated with significant blood loss when compared to other types&#xD;
      of joint surgeries. In order to try and avoid bleeding that may lead to complications,&#xD;
      different strategies can be used. In this research study the investigators want to learn more&#xD;
      about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized placebo controlled double blind trial will enroll 80 adolescents&#xD;
      and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to&#xD;
      determine if intravenous infusion of TXA during surgery is effective compared to standard&#xD;
      care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion&#xD;
      (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO&#xD;
      surgery. The rate of blood loss over time will be measured and compared between groups with&#xD;
      adjustment for length of surgery (time; hours) and body weight (kg).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigators decided not to begin the study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2019</start_date>
  <completion_date type="Actual">July 23, 2019</completion_date>
  <primary_completion_date type="Actual">July 23, 2019</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>
    <intervention_model_description>Patients who choose to participate will be randomized to receive either:&#xD;
placebo i.e. saline 0.9% (intravenous injection) (Control Group) or&#xD;
intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood loss</measure>
    <time_frame>1 week after surgery</time_frame>
    <description>ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma TXA level</measure>
    <time_frame>24 hours</time_frame>
    <description>ug/mL</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Normal saline placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the participant will get saline 0.9% intravenous infusion for the duration of the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous Tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous TXA will be given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic Acid</intervention_name>
    <description>Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery</description>
    <arm_group_label>Intravenous Tranexamic acid</arm_group_label>
    <other_name>TXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline infusion</description>
    <arm_group_label>Normal saline placebo</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
          -  Age 13-35 years&#xD;
&#xD;
          -  Scheduled for primary unilateral PAO +/- arthroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hematologic disorder, thrombocytopenia (Platelet count &lt;140,000/uL3)&#xD;
&#xD;
          -  Major hepatic, renal, or vascular disorder&#xD;
&#xD;
          -  Active Thromboembolic disorder&#xD;
&#xD;
          -  Color vision defect&#xD;
&#xD;
          -  TXA allergy&#xD;
&#xD;
          -  Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)&#xD;
&#xD;
          -  Ethical and/or religious objection to receiving blood products&#xD;
&#xD;
          -  International patients&#xD;
&#xD;
          -  Patients undergoing revision surgery&#xD;
&#xD;
          -  Patients undergoing combined PAO and other surgeries such as surgical dislocation,&#xD;
             proximal femoral osteotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Goobie, MD, FRPCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston children hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Maruyama M. CORR Insights((R)): Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Nov;473(11):3602-3. doi: 10.1007/s11999-015-4455-y. Epub 2015 Sep 9. No abstract available.</citation>
    <PMID>26354175</PMID>
  </reference>
  <reference>
    <citation>Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.</citation>
    <PMID>15791100</PMID>
  </reference>
  <reference>
    <citation>Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.</citation>
    <PMID>21364458</PMID>
  </reference>
  <reference>
    <citation>Wingerter SA, Keith AD, Schoenecker PL, Baca GR, Clohisy JC. Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Aug;473(8):2639-43. doi: 10.1007/s11999-015-4334-6. Epub 2015 May 20.</citation>
    <PMID>25991434</PMID>
  </reference>
  <reference>
    <citation>Goobie SM, Gallagher T, Gross I, Shander A. Society for the advancement of blood management administrative and clinical standards for patient blood management programs. 4th edition (pediatric version). Paediatr Anaesth. 2019 Mar;29(3):231-236. doi: 10.1111/pan.13574.</citation>
    <PMID>30609198</PMID>
  </reference>
  <reference>
    <citation>Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.</citation>
    <PMID>30516625</PMID>
  </reference>
  <reference>
    <citation>Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.</citation>
    <PMID>29120963</PMID>
  </reference>
  <reference>
    <citation>Goobie SM, Frank SM. Tranexamic Acid: What Is Known and Unknown, and Where Do We Go From Here? Anesthesiology. 2017 Sep;127(3):405-407. doi: 10.1097/ALN.0000000000001788. No abstract available.</citation>
    <PMID>28696996</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>October 2, 2019</last_update_submitted>
  <last_update_submitted_qc>October 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Susan Goobie</investigator_full_name>
    <investigator_title>Associate Professor of Anaesthesiology, Harvard Medical School Associate in Perioperative Anesthesia, Boston Children's Hospital Clinical Director, Pharmacokinetics Laboratory.</investigator_title>
  </responsible_party>
  <keyword>Tranexamic Acid</keyword>
  <keyword>Periacetabular Osteotomy</keyword>
  <keyword>Bleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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>No</sharing_ipd>
  </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/NCT03823417
org study id: IRB-P00030426
nct id: NCT03823417
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
In this research study the investigators want to learn more about how a medication called
      tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO)
      surgery. TXA is approved by the Food and Drug Administration (FDA) for the reduction of
      bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood
      clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively
      prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.

      As PAO surgery has been associated with significant blood loss when compared to other types
      of joint surgeries. In order to try and avoid bleeding that may lead to complications,
      different strategies can be used. In this research study the investigators want to learn more
      about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO
      surgery.
This prospective randomized placebo controlled double blind trial will enroll 80 adolescents
      and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to
      determine if intravenous infusion of TXA during surgery is effective compared to standard
      care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion
      (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO
      surgery. The rate of blood loss over time will be measured and compared between groups with
      adjustment for length of surgery (time; hours) and body weight (kg).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients who choose to participate will be randomized to receive either:
placebo i.e. saline 0.9% (intravenous injection) (Control Group) or
intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Blood loss
time frame: 1 week after surgery
description: ml
measure: Plasma TXA level
time frame: 24 hours
description: ug/mL
arm group label: Normal saline placebo
arm group type: Placebo Comparator
description: the participant will get saline 0.9% intravenous infusion for the duration of the surgery
arm group label: Intravenous Tranexamic acid
arm group type: Experimental
description: Intravenous TXA will be given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
intervention type: Drug
intervention name: Tranexamic Acid
description: Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
arm group label: Intravenous Tranexamic acid
other name: TXA
intervention type: Drug
intervention name: Normal saline
description: Normal saline infusion
arm group label: Normal saline placebo
other name: placebo
criteria: 
gender: All
minimum age: 13 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Goobie, MD, FRPCP
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
citation: Maruyama M. CORR Insights((R)): Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Nov;473(11):3602-3. doi: 10.1007/s11999-015-4455-y. Epub 2015 Sep 9. No abstract available.
PMID: 26354175
citation: Sethna NF, Zurakowski D, Brustowicz RM, Bacsik J, Sullivan LJ, Shapiro F. Tranexamic acid reduces intraoperative blood loss in pediatric patients undergoing scoliosis surgery. Anesthesiology. 2005 Apr;102(4):727-32. doi: 10.1097/00000542-200504000-00006.
PMID: 15791100
citation: Goobie SM, Meier PM, Pereira LM, McGowan FX, Prescilla RP, Scharp LA, Rogers GF, Proctor MR, Meara JG, Soriano SG, Zurakowski D, Sethna NF. Efficacy of tranexamic acid in pediatric craniosynostosis surgery: a double-blind, placebo-controlled trial. Anesthesiology. 2011 Apr;114(4):862-71. doi: 10.1097/ALN.0b013e318210fd8f.
PMID: 21364458
citation: Wingerter SA, Keith AD, Schoenecker PL, Baca GR, Clohisy JC. Does Tranexamic Acid Reduce Blood Loss and Transfusion Requirements Associated With the Periacetabular Osteotomy? Clin Orthop Relat Res. 2015 Aug;473(8):2639-43. doi: 10.1007/s11999-015-4334-6. Epub 2015 May 20.
PMID: 25991434
citation: Goobie SM, Gallagher T, Gross I, Shander A. Society for the advancement of blood management administrative and clinical standards for patient blood management programs. 4th edition (pediatric version). Paediatr Anaesth. 2019 Mar;29(3):231-236. doi: 10.1111/pan.13574.
PMID: 30609198
citation: Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.
PMID: 30516625
citation: Johnson DJ, Johnson CC, Goobie SM, Nami N, Wetzler JA, Sponseller PD, Frank SM. High-dose Versus Low-dose Tranexamic Acid to Reduce Transfusion Requirements in Pediatric Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e552-e557. doi: 10.1097/BPO.0000000000000820.
PMID: 29120963
citation: Goobie SM, Frank SM. Tranexamic Acid: What Is Known and Unknown, and Where Do We Go From Here? Anesthesiology. 2017 Sep;127(3):405-407. doi: 10.1097/ALN.0000000000001788. No abstract available.
PMID: 28696996
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Susan Goobie
investigator title: Associate Professor of Anaesthesiology, Harvard Medical School Associate in Perioperative Anesthesia, Boston Children's Hospital Clinical Director, Pharmacokinetics Laboratory.
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: No