<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/NCT04494126</url>
  </required_header>
  <id_info>
    <org_study_id>CMSNepal1</org_study_id>
    <nct_id>NCT04494126</nct_id>
  </id_info>
  <brief_title>Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma</brief_title>
  <official_title>Effect of Perioperative Tranexamic Acid on Blood Loss During Management of Maxillofacial Trauma: A Randomized Double Blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>College of Medical Sciences Teaching Hospital. Nepal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>College of Medical Sciences Teaching Hospital. Nepal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized, double-blind study investigating whether intravenous&#xD;
      tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the&#xD;
      subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and&#xD;
      edema are objectively rated and complications are noted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, double-blind pilot study investigating whether intravenous&#xD;
      tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the&#xD;
      subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia&#xD;
      chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous&#xD;
      events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days&#xD;
      1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for&#xD;
      statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 15, 2021</start_date>
  <completion_date type="Anticipated">December 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2021</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>Randomized, double-blind, Parallel assignment</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>Surgical period</time_frame>
    <description>Measured and recorded from the anaesthesia patient chart</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative bleeding event</measure>
    <time_frame>upto 48 hours after surgery</time_frame>
    <description>postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Complications if any during surgery and upto 48 hours after surgery</measure>
    <time_frame>upto 48 hours after surgery</time_frame>
    <description>complications related to surgery as reported by patient and clinician</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Blood Loss</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.</description>
    <arm_group_label>Tranexamic acid</arm_group_label>
    <other_name>Injection TXA 1 gram</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing ORIF under GA for Maxillofacial fractures&#xD;
&#xD;
          -  Patients between with ages of 16-65&#xD;
&#xD;
          -  No cardiac comorbidities (hypertension, congenital heart malformation)&#xD;
&#xD;
          -  No known coagulopathy&#xD;
&#xD;
          -  No regular prescription medication altering normal blood coagulation (NSAIDs, other&#xD;
             anticoagulants)&#xD;
&#xD;
          -  ASA I and II patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 16 and older than 65&#xD;
&#xD;
          -  Patients with known coagulopathy&#xD;
&#xD;
          -  Patients with cardiac comorbidities&#xD;
&#xD;
          -  Patients with a family history of bleeding disorders&#xD;
&#xD;
          -  ASA III or higher&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rajesh Yadav, MD</last_name>
    <role>Study Director</role>
    <affiliation>College of Medical Sciences Teaching hospital, Bharatpur, Nepal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ashutosh K Singh, MDS</last_name>
    <phone>+9779855082369</phone>
    <email>dr.ashutosh@cmsnepel.edu.np</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ashutosh K Singh, MDS</last_name>
    <phone>+9779804244369</phone>
    <email>drashutoshkumarsingh@gmail.com</email>
  </overall_contact_backup>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 1, 2021</last_update_submitted>
  <last_update_submitted_qc>August 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>College of Medical Sciences Teaching Hospital. Nepal</investigator_affiliation>
    <investigator_full_name>Ashutosh Kumar Singh</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Maxillofacial trauma; blood loss</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>
    <ipd_description>The data will be used for internal use only. Any patient identifier will be removed from the final master chart before statistical analysis.</ipd_description>
  </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/NCT04494126
org study id: CMSNepal1
nct id: NCT04494126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, randomized, double-blind study investigating whether intravenous
      tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the
      subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and
      edema are objectively rated and complications are noted.
This is a prospective, randomized, double-blind pilot study investigating whether intravenous
      tranexamic acid has any effect on blood loss during maxillofacial trauma surgery, or the
      subsequent postoperative sequelae. Intraoperative bleeding is calculated from anaesthesia
      chart and recorded in ml. Postoperative ecchymosis and bleeding are recorded as dichotomous
      events (yes/no) and are subjectively rated by both patient and surgeon on postoperative days
      1and 2. Any surgical or postoperative complications are noted. Scores are aggregated for
      statistical analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, double-blind, Parallel assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Only the anaesthesiologist who is administering the medications is unmasked until completion of the data collection period.
measure: Intraoperative blood loss
time frame: Surgical period
description: Measured and recorded from the anaesthesia patient chart
measure: Postoperative bleeding event
time frame: upto 48 hours after surgery
description: postoperative bleeding and ecchymosis subjectively reported by patient and assessed by clinician, recorded as a dichotomous outcome.
measure: Complications if any during surgery and upto 48 hours after surgery
time frame: upto 48 hours after surgery
description: complications related to surgery as reported by patient and clinician
arm group label: Tranexamic acid
arm group type: Experimental
description: Experimental: TXA Group One gram of intravenous tranexamic acid (TXA) in normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Comparator: Control Group Intravenous normal saline (50cc) given over 15 minutes starting just prior to skin incision, and repeated 6 hours later in the postoperative period.
intervention type: Drug
intervention name: Tranexamic acid
description: Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.
arm group label: Tranexamic acid
other name: Injection TXA 1 gram
intervention type: Drug
intervention name: Placebo
description: Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
arm group label: Placebo
other name: Normal saline
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rajesh Yadav, MD
role: Study Director
affiliation: College of Medical Sciences Teaching hospital, Bharatpur, Nepal
last name: Ashutosh K Singh, MDS
phone: +9779855082369
email: dr.ashutosh@cmsnepel.edu.np
last name: Ashutosh K Singh, MDS
phone: +9779804244369
email: drashutoshkumarsingh@gmail.com
responsible party type: Principal Investigator
investigator affiliation: College of Medical Sciences Teaching Hospital. Nepal
investigator full name: Ashutosh Kumar Singh
investigator title: Associate professor
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: No
ipd description: The data will be used for internal use only. Any patient identifier will be removed from the final master chart before statistical analysis.