<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/NCT04430777</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT04430777</nct_id>
  </id_info>
  <brief_title>Use of Tranexamic Acid in Liposculpture</brief_title>
  <official_title>Use of Tranexamic Acid in Liposculpture: A Double-blind, Multicenter, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Total Definer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Total Definer Research Group</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Blood loss during a surgical procedure is inevitable, its reduction is a key factor for&#xD;
      surgical success. Also, to avoid progress to severe complications like hemodynamic&#xD;
      decompensation, cardiac arrest or the need to blood transfusions. According to the Center for&#xD;
      Disease Control (CDC), there is a usage of more than 17 million transfused blood products&#xD;
      units per year. Blood transfusion is a convenient technique for reposition of blood during&#xD;
      major bleed, but it involves several probable complications like anaphylaxis, bloodborne&#xD;
      infections and others. Consequently, meticulous hemostasis during surgery is crucial to&#xD;
      diminish blood loss.&#xD;
&#xD;
      Hemostatic agents play a pivotal role during surgical time. Amongst them topical,&#xD;
      energy-based and systemic agents are the vast majority. Tranexamic acid (TXA) is a lysine&#xD;
      synthetic derivate that inhibits fibrinolysis by blocking the 5 lysine-binding sites to&#xD;
      plasminogen. It has been used in clinical practice since 1962 and become very popular after&#xD;
      2010 when the CRASH-2 study showed a decreased risk of death in trauma patients.&#xD;
&#xD;
      Tranexamic acid use is widely extended among diverse surgical fields: orthopedics, cardiac&#xD;
      surgery and obstetrics. In plastic surgery it uses is limited mainly to craniofacial surgery&#xD;
      as a local agent. The aim of this trial is to show the efficacy of tranexamic acid as&#xD;
      hemostatic agent in liposuction and to compare its efficacy among different administration&#xD;
      routes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 3 plastic surgery centers, the investigators randomized patients in a double-blind,&#xD;
      randomized, controlled trial comparing the clinical outcomes of different administration&#xD;
      routes of TXA, intravenous versus subcutaneous versus placebo between January 2019 to&#xD;
      February 2020. The study was approved by the Ethics committee at the central coordinating&#xD;
      center and at each of the participating sites. The centers of the study were, Dhara clinic,&#xD;
      Bogota, Colombia, Centro Medico de las Americas clinic, in Mérida, Mexico and Innovare&#xD;
      hospital in Jalisco, Mexico. Once a month, the investigators performed only meetings between&#xD;
      the researcher coordinator and delegates from each of the centers to audit the data&#xD;
      collection and information registration.&#xD;
&#xD;
      During the preoperative consultation, the study interventions were explained clearly to each&#xD;
      participants. Participants were given adequate time to ponder the information, had any&#xD;
      questions answered and gave their free and voluntary consent. A total of 141 participants&#xD;
      were recollected. The primary outcome was the difference regarding to hemoglobin loss points&#xD;
      between groups. All patients had hemoglobin and hematocrit tests taken prior to surgery, 24&#xD;
      hours postoperatively and 5 days postoperatively. The investigators determined the hemoglobin&#xD;
      loss points in each group by deduct the postoperative hemoglobin at day one to the&#xD;
      preoperative hemoglobin (For hemoglobin loss at day 1) and the postoperative hemoglobin at&#xD;
      day five to the preoperative hemoglobin (For hemoglobin loss at day 5). As a secondary&#xD;
      outcome, the investigators performed a subgroup analysis to determine the difference in&#xD;
      hematological parameters (hemoglobin and hematocrit) between the groups.&#xD;
&#xD;
      Sample size and Statistical Analysis Sample size was calculated using the online app from&#xD;
      sealed envelope where 96 patients were required to have a 90% of chance of detecting, as&#xD;
      significant at the 5% level, a difference between the mean postoperative Hb value from 10.5&#xD;
      g/dl in the control group to 11.5 g/dl in the experimental group and an estimated standard&#xD;
      deviation (SD) of 1.5 g/dl. Since, the investigators planned two experimental approaches:&#xD;
      Subcutaneous (SC) TA and Intravenous (IV) TA; 141 patients were randomized into 3 groups: 1.&#xD;
      IV-TA group (n=47), 2. SC-TA group (n=47) and NS group. Demographic and clinical&#xD;
      characteristics were described, hematological parameters were analyzed per group before&#xD;
      surgery, at the immediate post-operative period, and at the fifth post-operative day. The&#xD;
      descriptive analysis was made through means and medians according to the distribution of&#xD;
      variables.&#xD;
&#xD;
      For categorical variables, counts and percentages were used. The quantitative variables with&#xD;
      parametric distribution were compared using ANOVA, and for variables with non-parametric&#xD;
      distribution using Kruskal-Wallis test, while the frequencies of the qualitative variables&#xD;
      were compared using Chi2 test. We used a boxplot to illustrate the differences between the&#xD;
      means of the hemoglobin by group. Bilateral hypotheses were formulated at two tails with&#xD;
      significance level less than 0.05. The data were collected in Microsoft excel and the&#xD;
      statistical analysis were performed in the statistical program STATA version 15.0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">February 22, 2020</completion_date>
  <primary_completion_date type="Actual">February 22, 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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 were randomly assigned to three groups: Placebo group, intravenous group and subcutaneous group according to the administration route of tranexamic acid</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hemoglobin</measure>
    <time_frame>Change from Baseline Hemoglobin at first posoperative and fifth posoperative day</time_frame>
    <description>All patients had hemoglobin tests taken prior to surgery, 24 hours postoperatively and 5 days postoperatively. We determine the hemoglobin loss points in each group by deduct the postoperative hemoglobin at day one to the preoperative hemoglobin (For hemoglobin loss at day 1) and the postoperative hemoglobin at day five to the preoperative hemoglobin (For hemoglobin loss at day 5).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No use of tranexamic acid. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 1 gr of tranexamic acid (10 ml) IV, thirty minutes previous to the initiation of the surgery. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcutaneous group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 1 gr of tranexamic acid (10 ml) in the total of the infiltration mixture, as follow:&#xD;
4 liters of infiltration contents 2.5 ml of tranexamic acid plus 1 mg epinephrine 5 liters of infiltration contents 2 ml of tranexamic acid plus 1 mg epinephrine.&#xD;
6 liters of infiltration contents 1.6 ml of tranexamic acid plus 1 mg epinephrine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Administration of tranexamic acid 1 gr either intravenously or subcutaneously</description>
    <arm_group_label>Intravenous group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Subcutaneous group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that underwent liposculpture as unique procedure, surgical time between 2 and&#xD;
             5 hours, age between 20 and 45 years old and BMI between 20 and 30 m2/kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that were operated of liposculpture and any additional procedure&#xD;
             (Mammoplasty, tummy tuck, etc.), patients with history of thromboembolic disease or in&#xD;
             Treatment with aspirin within 14 days before surgery or anticoagulants within 5 days&#xD;
             prior to surgery, patients with history of epilepsy, patients with allergy to&#xD;
             tranexamic acid, comorbidity grade III or IV according to ASA (American society of&#xD;
             Anesthesiologists) and patients with prothrombin time (PT) and/or activated partial&#xD;
             thromboplastin time (aPTT) &gt;1.5 times the baseline.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dhara clinic</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovare hospital</name>
      <address>
        <city>Jalisco</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico de las Americas clinic</name>
      <address>
        <city>Merida</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013 Sep;100(10):1271-9. doi: 10.1002/bjs.9193. Epub 2013 Jul 9.</citation>
    <PMID>23839785</PMID>
  </reference>
  <reference>
    <citation>Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926.</citation>
    <PMID>28938364</PMID>
  </reference>
  <reference>
    <citation>Taam J, Yang QJ, Pang KS, Karanicolas P, Choi S, Wasowicz M, Jerath A. Current Evidence and Future Directions of Tranexamic Acid Use, Efficacy, and Dosing for Major Surgical Procedures. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):782-790. doi: 10.1053/j.jvca.2019.06.042. Epub 2019 Jul 4.</citation>
    <PMID>31455576</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Total Definer Research Group</investigator_affiliation>
    <investigator_full_name>Alfredo Hoyos</investigator_full_name>
    <investigator_title>Plastic Surgeon, Head of Total Definer Research Group</investigator_title>
  </responsible_party>
  <keyword>Tranexamic Acid</keyword>
  <keyword>Blood Loss</keyword>
  <keyword>Liposculpture</keyword>
  <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>
  <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/NCT04430777
org study id: 1
nct id: NCT04430777
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Blood loss during a surgical procedure is inevitable, its reduction is a key factor for
      surgical success. Also, to avoid progress to severe complications like hemodynamic
      decompensation, cardiac arrest or the need to blood transfusions. According to the Center for
      Disease Control (CDC), there is a usage of more than 17 million transfused blood products
      units per year. Blood transfusion is a convenient technique for reposition of blood during
      major bleed, but it involves several probable complications like anaphylaxis, bloodborne
      infections and others. Consequently, meticulous hemostasis during surgery is crucial to
      diminish blood loss.

      Hemostatic agents play a pivotal role during surgical time. Amongst them topical,
      energy-based and systemic agents are the vast majority. Tranexamic acid (TXA) is a lysine
      synthetic derivate that inhibits fibrinolysis by blocking the 5 lysine-binding sites to
      plasminogen. It has been used in clinical practice since 1962 and become very popular after
      2010 when the CRASH-2 study showed a decreased risk of death in trauma patients.

      Tranexamic acid use is widely extended among diverse surgical fields: orthopedics, cardiac
      surgery and obstetrics. In plastic surgery it uses is limited mainly to craniofacial surgery
      as a local agent. The aim of this trial is to show the efficacy of tranexamic acid as
      hemostatic agent in liposuction and to compare its efficacy among different administration
      routes.
In 3 plastic surgery centers, the investigators randomized patients in a double-blind,
      randomized, controlled trial comparing the clinical outcomes of different administration
      routes of TXA, intravenous versus subcutaneous versus placebo between January 2019 to
      February 2020. The study was approved by the Ethics committee at the central coordinating
      center and at each of the participating sites. The centers of the study were, Dhara clinic,
      Bogota, Colombia, Centro Medico de las Americas clinic, in Mérida, Mexico and Innovare
      hospital in Jalisco, Mexico. Once a month, the investigators performed only meetings between
      the researcher coordinator and delegates from each of the centers to audit the data
      collection and information registration.

      During the preoperative consultation, the study interventions were explained clearly to each
      participants. Participants were given adequate time to ponder the information, had any
      questions answered and gave their free and voluntary consent. A total of 141 participants
      were recollected. The primary outcome was the difference regarding to hemoglobin loss points
      between groups. All patients had hemoglobin and hematocrit tests taken prior to surgery, 24
      hours postoperatively and 5 days postoperatively. The investigators determined the hemoglobin
      loss points in each group by deduct the postoperative hemoglobin at day one to the
      preoperative hemoglobin (For hemoglobin loss at day 1) and the postoperative hemoglobin at
      day five to the preoperative hemoglobin (For hemoglobin loss at day 5). As a secondary
      outcome, the investigators performed a subgroup analysis to determine the difference in
      hematological parameters (hemoglobin and hematocrit) between the groups.

      Sample size and Statistical Analysis Sample size was calculated using the online app from
      sealed envelope where 96 patients were required to have a 90% of chance of detecting, as
      significant at the 5% level, a difference between the mean postoperative Hb value from 10.5
      g/dl in the control group to 11.5 g/dl in the experimental group and an estimated standard
      deviation (SD) of 1.5 g/dl. Since, the investigators planned two experimental approaches:
      Subcutaneous (SC) TA and Intravenous (IV) TA; 141 patients were randomized into 3 groups: 1.
      IV-TA group (n=47), 2. SC-TA group (n=47) and NS group. Demographic and clinical
      characteristics were described, hematological parameters were analyzed per group before
      surgery, at the immediate post-operative period, and at the fifth post-operative day. The
      descriptive analysis was made through means and medians according to the distribution of
      variables.

      For categorical variables, counts and percentages were used. The quantitative variables with
      parametric distribution were compared using ANOVA, and for variables with non-parametric
      distribution using Kruskal-Wallis test, while the frequencies of the qualitative variables
      were compared using Chi2 test. We used a boxplot to illustrate the differences between the
      means of the hemoglobin by group. Bilateral hypotheses were formulated at two tails with
      significance level less than 0.05. The data were collected in Microsoft excel and the
      statistical analysis were performed in the statistical program STATA version 15.0.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients were randomly assigned to three groups: Placebo group, intravenous group and subcutaneous group according to the administration route of tranexamic acid
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in hemoglobin
time frame: Change from Baseline Hemoglobin at first posoperative and fifth posoperative day
description: All patients had hemoglobin tests taken prior to surgery, 24 hours postoperatively and 5 days postoperatively. We determine the hemoglobin loss points in each group by deduct the postoperative hemoglobin at day one to the preoperative hemoglobin (For hemoglobin loss at day 1) and the postoperative hemoglobin at day five to the preoperative hemoglobin (For hemoglobin loss at day 5).
arm group label: Placebo group
arm group type: Placebo Comparator
description: No use of tranexamic acid. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.
arm group label: Intravenous group
arm group type: Experimental
description: A single dose of 1 gr of tranexamic acid (10 ml) IV, thirty minutes previous to the initiation of the surgery. Subcutaneous infiltration of normal saline solution plus 1 mg of epinephrine as required for the procedure.
arm group label: Subcutaneous group
arm group type: Experimental
description: A single dose of 1 gr of tranexamic acid (10 ml) in the total of the infiltration mixture, as follow:
4 liters of infiltration contents 2.5 ml of tranexamic acid plus 1 mg epinephrine 5 liters of infiltration contents 2 ml of tranexamic acid plus 1 mg epinephrine.
6 liters of infiltration contents 1.6 ml of tranexamic acid plus 1 mg epinephrine.
intervention type: Drug
intervention name: Tranexamic acid
description: Administration of tranexamic acid 1 gr either intravenously or subcutaneously
arm group label: Intravenous group
arm group label: Placebo group
arm group label: Subcutaneous group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Colombia
country: Mexico
citation: Ker K, Prieto-Merino D, Roberts I. Systematic review, meta-analysis and meta-regression of the effect of tranexamic acid on surgical blood loss. Br J Surg. 2013 Sep;100(10):1271-9. doi: 10.1002/bjs.9193. Epub 2013 Jul 9.
PMID: 23839785
citation: Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926.
PMID: 28938364
citation: Taam J, Yang QJ, Pang KS, Karanicolas P, Choi S, Wasowicz M, Jerath A. Current Evidence and Future Directions of Tranexamic Acid Use, Efficacy, and Dosing for Major Surgical Procedures. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):782-790. doi: 10.1053/j.jvca.2019.06.042. Epub 2019 Jul 4.
PMID: 31455576
responsible party type: Principal Investigator
investigator affiliation: Total Definer Research Group
investigator full name: Alfredo Hoyos
investigator title: Plastic Surgeon, Head of Total Definer Research Group
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Tranexamic Acid
sharing ipd: No