xml: <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/NCT06038981</url>
    </required_header>
    <id_info>
      <org_study_id>TXA_SG</org_study_id>
      <nct_id>NCT06038981</nct_id>
    </id_info>
    <brief_title>Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial</brief_title>
    <official_title>Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Gdansk</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Gdansk</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>
        Enhanced recovery after bariatric surgery imposes a significant reduction in length of&#xD;
        hospital stay. However beneficial for the overall recovery it reduces the hospital&#xD;
        observation time. after a laparoscopic surgery during which one of the longest resection line&#xD;
        in surgery or anastomosis are created. Therefore, discovering possible safe and effective&#xD;
        ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative&#xD;
        bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid&#xD;
        (TXA) has been shown to be effective in many types of surgery, reducing the incidence of&#xD;
        post-operative bleeding and thereby reducing the rate of reoperation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim:&#xD;
  &#xD;
        To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric&#xD;
        surgeriessleeve gastrectomy operation.&#xD;
  &#xD;
        Material and methods:&#xD;
  &#xD;
        A single-blind randomized clinical trial in the high-volume bariatric center of excellence.&#xD;
  &#xD;
        Patients undergoing highly standardized bariatric procedures, meeting the inclusion and&#xD;
        exclusion criteria were included in the study, sample size determined by power study&#xD;
        evaluation.&#xD;
  &#xD;
        Randomization scheme was a weekly surgery schedule. Patients were randomized to 2 groups: TXA&#xD;
        (administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced) od&#xD;
        CG (no tranexamic acid administration).&#xD;
  &#xD;
        Patients were evaluated on the postoperative day 1 by standard lab tests included in the&#xD;
        center's protocol, additionally measuring the volume of drainage and heamoglobin&#xD;
        concentration in the drainage sample.&#xD;
  &#xD;
        1-month follow-up observation involving interviewing, examining and conducting lab tests of&#xD;
        the study group was provided to determine the safety profile and possible occurrence of TXA&#xD;
        complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 4, 2022</start_date>
    <completion_date type="Actual">June 28, 2023</completion_date>
    <primary_completion_date type="Actual">June 28, 2023</primary_completion_date>
    <phase>N/A</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 (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood loss.</measure>
      <time_frame>First postoperative day.</time_frame>
      <description>Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>TXA complications.</measure>
      <time_frame>One month.</time_frame>
      <description>1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">300</enrollment>
    <condition>Hemorrhage, Surgical</condition>
    <condition>Bariatric Surgery</condition>
    <condition>Tranexamic Acid</condition>
    <arm_group>
      <arm_group_label>Control Group (CG).</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no tranexamic acid administration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TXA group.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced</intervention_name>
      <description>The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.&#xD;
  To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeries (sleeve gastrectomy operation)</description>
      <arm_group_label>TXA group.</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant were adults qualified for bariatric procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Primary (pre-operative) exclusion criteria were as follows:&#xD;
  &#xD;
          Usage of anticoagulative agents in the perioperative period including:&#xD;
  &#xD;
          Indirect thrombin inhibitors (Fondaparinux, UFH, LMWH in therapeutic dosing) Direct&#xD;
          inhibitors of factor Xa (NOAC) Direct thrombin inhibitors (Dabigatran) Vitamin K&#xD;
          Antagonists (VKA: acenokumarol, warfarin) Platelet aggregation inhibitors (excluding ASA in&#xD;
          dosing 75mg per day) P2Y12 receptor inhibitors Prior diagnosis of congenital or acquired&#xD;
          blood coagulation disorders Diagnosed allergic reactions to TXA in medical history Chronic&#xD;
          Kidney Disease in stage G3 or higher Chronic hemodialysis Haematuria in medical history&#xD;
          Seizures in medical history&#xD;
  &#xD;
          To achieve the most homogenous group of patients and to reduce possible bias due to&#xD;
          additional interventions occurring during the operation - further, postoperative exclusion&#xD;
          criteria were introduced:&#xD;
  &#xD;
          Performed operation other than laparoscopic sleeve gastrectomy (LSG) Necessity of TXA&#xD;
          administration in the postoperative period Additional, supplementary heamostatic materials&#xD;
          and methods were used during the operation - deviation from the standard operation protocol&#xD;
          (attachment 1), such as: use of oxidized regenerative cellulose (ORC), cyanoacrylate&#xD;
          laparoscopic bioglue (IfabondÒ, Peters Surgical), staple-line reinforcement.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medical University of Gdańsk</name>
        <address>
          <city>Gdańsk</city>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>bariatric surgery</keyword>
    <keyword>Hemorrhage</keyword>
    <keyword>Tranexamic Acid</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>Undecided</sharing_ipd>
      <ipd_description>Study Protocol and SAP will be available soon online.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038981
  org study id: TXA_SG
  nct id: NCT06038981
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Enhanced recovery after bariatric surgery imposes a significant reduction in length of
        hospital stay. However beneficial for the overall recovery it reduces the hospital
        observation time. after a laparoscopic surgery during which one of the longest resection line
        in surgery or anastomosis are created. Therefore, discovering possible safe and effective
        ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative
        bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid
        (TXA) has been shown to be effective in many types of surgery, reducing the incidence of
        post-operative bleeding and thereby reducing the rate of reoperation.
  Aim:
  
        To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric
        surgeriessleeve gastrectomy operation.
  
        Material and methods:
  
        A single-blind randomized clinical trial in the high-volume bariatric center of excellence.
  
        Patients undergoing highly standardized bariatric procedures, meeting the inclusion and
        exclusion criteria were included in the study, sample size determined by power study
        evaluation.
  
        Randomization scheme was a weekly surgery schedule. Patients were randomized to 2 groups: TXA
        (administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced) od
        CG (no tranexamic acid administration).
  
        Patients were evaluated on the postoperative day 1 by standard lab tests included in the
        center's protocol, additionally measuring the volume of drainage and heamoglobin
        concentration in the drainage sample.
  
        1-month follow-up observation involving interviewing, examining and conducting lab tests of
        the study group was provided to determine the safety profile and possible occurrence of TXA
        complications.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  measure: Blood loss.
  time frame: First postoperative day.
  description: Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.
  measure: TXA complications.
  time frame: One month.
  description: 1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications.
  arm group label: Control Group (CG).
  arm group type: No Intervention
  description: no tranexamic acid administration.
  arm group label: TXA group.
  arm group type: Experimental
  description: Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.
  intervention type: Drug
  intervention name: Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced
  description: The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.
  To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeries (sleeve gastrectomy operation)
  arm group label: TXA group.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Hemorrhage
  mesh term: Blood Loss, Surgical
  mesh term: Tranexamic Acid
  sharing ipd: Undecided
  ipd description: Study Protocol and SAP will be available soon online.