<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/NCT04488367</url>
  </required_header>
  <id_info>
    <org_study_id>TXARCT1</org_study_id>
    <nct_id>NCT04488367</nct_id>
  </id_info>
  <brief_title>Blood Loss After Early TXA in Hip Fractures.</brief_title>
  <official_title>The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Community Memorial Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Community Memorial 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>
      Our present study aims to initiate TXA administration immediately upon diagnosis of hip&#xD;
      fracture in the Emergency Department. This will be a single blind randomized controlled trial&#xD;
      comparing early administration of TXA in the ED in addition to perioperative dosing versus&#xD;
      the standard perioperative administration only. The study population will include patients&#xD;
      who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and&#xD;
      are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the&#xD;
      need for blood transfusion, total and hidden blood loss, postoperative complications, length&#xD;
      of stay and readmission within 30 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consent will be obtained for study enrollment from the patient or legal decision maker. The&#xD;
      patient will then be randomized and stratified based on the fracture type, fixation method&#xD;
      anticipated, and presence of anticoagulation.&#xD;
&#xD;
      Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients&#xD;
      will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then&#xD;
      receive repeat doses prior to skin incision and again after the end of surgery. Control group&#xD;
      will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA&#xD;
      doses prior to surgery and again after the end of surgery. The perioperative doses will not&#xD;
      be blinded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</primary_completion_date>
  <phase>Early Phase 1</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>Change in calculated and recorded hemoglobin</measure>
    <time_frame>From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.</time_frame>
    <description>Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total postoperative units of red blood cell transfusion</measure>
    <time_frame>From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.</time_frame>
    <description>The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VTE</measure>
    <time_frame>Postoperative for 30 days</time_frame>
    <description>DVT or PE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>Postoperative for 30 days</time_frame>
    <description>Superficial and deep infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission</measure>
    <time_frame>Within 30 days postoperative</time_frame>
    <description>30 day readmission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other complications</measure>
    <time_frame>Postoperative for 30 days</time_frame>
    <description>Any additional unforeseen complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Early TXA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU</description>
    <arm_group_label>Early TXA</arm_group_label>
    <other_name>Early TXA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Femoral neck, intertrochanteric, subtrochanteric femur fracture&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  Undergoing surgical stabilization or arthroplasty by any method as determined by&#xD;
             attending surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18&#xD;
&#xD;
          -  Concomitant fracture&#xD;
&#xD;
          -  Preoperative anemia needing blood transfusion before surgery&#xD;
&#xD;
          -  Severe comorbidity (active cancer, severe pulmonary disease, ESRD)&#xD;
&#xD;
          -  Allergy for tranexamic acid&#xD;
&#xD;
          -  History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism,&#xD;
             Stroke, TIA) in the previous 12 months&#xD;
&#xD;
          -  Myocardial infarction in the previous 12 months&#xD;
&#xD;
          -  Renal function impairment (creatinine clearance &lt;30 mL/min), or kidney transplant&#xD;
&#xD;
          -  History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)&#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_official>
    <last_name>Michael Allen, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Resident physician</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Allen, DO</last_name>
    <phone>805-948-5100</phone>
    <email>mallen@cmhshealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Community Memorial Hospital</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Allen</last_name>
      <phone>805-948-5100</phone>
      <email>mallen@cmhshealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.</citation>
    <PMID>18349013</PMID>
  </reference>
  <reference>
    <citation>Praetorius K, Madsen CM, Abrahamsen B, Jorgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17.</citation>
    <PMID>27551568</PMID>
  </reference>
  <reference>
    <citation>CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.</citation>
    <PMID>20554319</PMID>
  </reference>
  <reference>
    <citation>Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.</citation>
    <PMID>28810918</PMID>
  </reference>
  <reference>
    <citation>Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. doi: 10.1177/1602400322.</citation>
    <PMID>28031511</PMID>
  </reference>
  <reference>
    <citation>Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.</citation>
    <PMID>28983887</PMID>
  </reference>
  <reference>
    <citation>Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2.</citation>
    <PMID>29426608</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Community Memorial Health System</investigator_affiliation>
    <investigator_full_name>Michael Allen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>tranexamic acid</keyword>
  <keyword>TXA</keyword>
  <keyword>hip fracture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</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/NCT04488367
org study id: TXARCT1
nct id: NCT04488367
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Our present study aims to initiate TXA administration immediately upon diagnosis of hip
      fracture in the Emergency Department. This will be a single blind randomized controlled trial
      comparing early administration of TXA in the ED in addition to perioperative dosing versus
      the standard perioperative administration only. The study population will include patients
      who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and
      are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the
      need for blood transfusion, total and hidden blood loss, postoperative complications, length
      of stay and readmission within 30 days.
Consent will be obtained for study enrollment from the patient or legal decision maker. The
      patient will then be randomized and stratified based on the fracture type, fixation method
      anticipated, and presence of anticoagulation.

      Treatment drug and saline placebo will be blinded from the patient. Treatment arm patients
      will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then
      receive repeat doses prior to skin incision and again after the end of surgery. Control group
      will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA
      doses prior to surgery and again after the end of surgery. The perioperative doses will not
      be blinded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in calculated and recorded hemoglobin
time frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
description: Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.
measure: Total postoperative units of red blood cell transfusion
time frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.
description: The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
measure: VTE
time frame: Postoperative for 30 days
description: DVT or PE
measure: Infection
time frame: Postoperative for 30 days
description: Superficial and deep infections
measure: Readmission
time frame: Within 30 days postoperative
description: 30 day readmission
measure: Other complications
time frame: Postoperative for 30 days
description: Any additional unforeseen complications
arm group label: Early TXA
arm group type: Experimental
description: Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
arm group label: Control
arm group type: Other
description: Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.
intervention type: Drug
intervention name: Tranexamic acid
description: 10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
arm group label: Early TXA
other name: Early TXA
intervention type: Drug
intervention name: Normal Saline
description: 100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
arm group label: Control
other name: Control Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Allen, DO
role: Principal Investigator
affiliation: Resident physician
last name: Michael Allen, DO
phone: 805-948-5100
email: mallen@cmhshealth.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.
PMID: 18349013
citation: Praetorius K, Madsen CM, Abrahamsen B, Jorgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17.
PMID: 27551568
citation: CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
PMID: 20554319
citation: Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.
PMID: 28810918
citation: Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. doi: 10.1177/1602400322.
PMID: 28031511
citation: Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.
PMID: 28983887
citation: Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2.
PMID: 29426608
responsible party type: Principal Investigator
investigator affiliation: Community Memorial Health System
investigator full name: Michael Allen
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Tranexamic Acid
sharing ipd: No