<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/NCT02261415</url>
  </required_header>
  <id_info>
    <org_study_id>244-2014</org_study_id>
    <nct_id>NCT02261415</nct_id>
  </id_info>
  <brief_title>The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial</brief_title>
  <acronym>HeLiX</acronym>
  <official_title>The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HepatoPancreaticoBiliary (HPB) Concept Team</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of&#xD;
      tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver&#xD;
      resection. The rationale for this study includes: (1) experimental evidence supporting the&#xD;
      use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver&#xD;
      resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons,&#xD;
      anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient&#xD;
      study design; and (5) the importance of the question: incidence of blood transfusion in&#xD;
      patients undergoing liver resection is high, and the consequences serious. The sample size&#xD;
      for this study is 1230 participants.Participants enrolled in the prior Vanguard study will&#xD;
      proceed directly into the RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose Compelling biological rationale and indirect evidence from other settings suggest&#xD;
      that there is potential benefit to administering TXA to patients undergoing liver resection.&#xD;
      A lack of consensus in the hepatobiliary community and lack of direct evidence in patients&#xD;
      undergoing liver resection mandate a RCT.&#xD;
&#xD;
      Hypothesis To determine the impact of perioperative administration of TXA to patients&#xD;
      undergoing liver resection on the need for blood transfusion and long-term survival.&#xD;
&#xD;
      Justification If TXA use in liver resection resulted in an important decrease in blood&#xD;
      transfusions, clinical practice worldwide would be likely to change. Over 2000 patients in&#xD;
      Canada undergo liver resection annually and could benefit from this simple, low-cost&#xD;
      intervention. This intervention could easily be implemented in other countries, where many&#xD;
      more patients undergo liver resection annually. Furthermore, TXA may be beneficial in other&#xD;
      operative fields where bleeding is a major problem, including thoracic surgery, colorectal&#xD;
      surgery, and many others.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
      The primary outcome of the RCT will be:&#xD;
&#xD;
      1) Receipt of blood transfusion (% transfused): 7 days&#xD;
&#xD;
      The secondary outcomes of the RCT are:&#xD;
&#xD;
        1. Intraoperative blood loss will be assessed by adding the net weight of sponges and fluid&#xD;
           suction (minus irrigation and intraoperative bile or other fluids in suction/sponge)&#xD;
&#xD;
        2. Total blood loss (postoperative day (POD)0 - POD7) will be assessed by Gross' formula,&#xD;
           which uses the maximum postoperative decrease in the level of hemoglobin adjusted for&#xD;
           the weight and height of the patient&#xD;
&#xD;
        3. Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)&#xD;
&#xD;
        4. Postoperative incidence of symptomatic venous thromboembolic event confirmed with either&#xD;
           computed tomography (CT) angiogram (for pulmonary embolism) or venous Doppler ultrasound&#xD;
           (for deep venous thrombosis) (within 90 days of surgery)&#xD;
&#xD;
        5. Postoperative complications (within 90 days of surgery) will be determined using the&#xD;
           Clavien-Dindo classification&#xD;
&#xD;
        6. Recurrence free survival (within 5 years of surgery) will be determined by review of&#xD;
           patient medical record every 6 months until 5 years post-surgery&#xD;
&#xD;
           a. Recurrence free survival is defined as the time from POD0 to the first event that is&#xD;
           recurrent (local or distal) cancer or death (from any cause)&#xD;
&#xD;
        7. Overall survival (within 5 years of surgery) will be determined by review of patient&#xD;
           medical record every 6 months until 5 years post-surgery&#xD;
&#xD;
           a. Overall survival is defined as the time from date of POD0 to death from any cause&#xD;
&#xD;
        8. QOL will be determined by administering European Organization for Research and Treatment&#xD;
           of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30 and the QLQ- Liver Metastases&#xD;
           Colorectal (LMC) 21 at baseline, 30 and 90 days following surgery&#xD;
&#xD;
        9. Perioperative mortality will be recorded between POD0 and POD7&#xD;
&#xD;
       10. Economic analysis will assess impact of TXA incorporation on health care resources and&#xD;
           strategies for systematic utilization of TXA&#xD;
&#xD;
      Research Method This is a Phase III multicentre randomized controlled trial (RCT) to evaluate&#xD;
      the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing&#xD;
      liver resection. The trial will conceal allocation, maximize possible blinding, independently&#xD;
      assess the appropriateness of transfusion, use strategies to limit loss to follow-up and&#xD;
      crossovers, and use a conservative stopping rule. Patients will be administered a single dose&#xD;
      of study drug intravenously immediately after induction of anaesthesia, followed by infusion&#xD;
      over eight hours.&#xD;
&#xD;
      Statistical Analysis Primary analysis will include only patients who underwent liver&#xD;
      resection; patients who are randomized but do not receive liver resection (usually due to&#xD;
      more advanced disease identified intraoperatively) will be excluded. A sensitivity analysis&#xD;
      will be conducted whereby all randomized patients are included in the assessment of the&#xD;
      primary outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Actual">August 2022</primary_completion_date>
  <phase>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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of blood transfusion (% transfused): 7 days</measure>
    <time_frame>7 days</time_frame>
    <description>Receipt of one or more RBC transfusions between Day 0 and Day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative blood loss</measure>
    <time_frame>7 days</time_frame>
    <description>Intraoperative blood loss will be assessed by adding the net weight of sponges and fluid suction (minus irrigation and intraoperative bile or other fluids in suction/sponge)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total blood loss</measure>
    <time_frame>7 days</time_frame>
    <description>Total blood loss (postoperative day (POD)0 - POD7) will be assessed by Gross' formula, which uses the maximum postoperative decrease in the level of hemoglobin adjusted for the weight and height of the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of packed red blood cells (PRBC) units transfused</measure>
    <time_frame>7 days</time_frame>
    <description>Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative incidence of symptomatic venous thromboembolic event</measure>
    <time_frame>90 days</time_frame>
    <description>Postoperative incidence of symptomatic venous thromboembolic event confirmed with either computed tomography (CT) angiogram (for pulmonary embolism) or venous Doppler ultrasound (for deep venous thrombosis) (within 90 days of surgery)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications assessed using Clavien-Dindo Grading System</measure>
    <time_frame>90 days</time_frame>
    <description>Postoperative complications (within 90 days of surgery) will be determined using the Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence Free Survival (within 5 years of surgery)</measure>
    <time_frame>60 months</time_frame>
    <description>Disease recurrence is defined as the clinical presence of cancer that has either been confirmed by biopsy, has had treatment initiated, or is documented in the treating physician's notes. Five year disease recurrence from day of surgery will be evaluated approximately every 6 months until 5 years via medical record review.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (within 5 years of surgery)</measure>
    <time_frame>60 months</time_frame>
    <description>Overall survival is defined as the time from date of surgery to death from any cause. It will be determined by review of patient medical record every 6 months until 5 years post-surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30</measure>
    <time_frame>Baseline, 30 days, 90 days</time_frame>
    <description>QOL will be determined by administering the EORTC QLQ-C30 at baseline, 30 and 90 days following surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Liver Module (LM)C21 Questionnaire</measure>
    <time_frame>Baseline, 30 days, 90 days</time_frame>
    <description>QOL will be determined by administering QLQ-LMC21 at baseline, 30 and 90 days following surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative mortality</measure>
    <time_frame>7 days</time_frame>
    <description>Perioperative mortality will be recorded between POD0 and POD7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the cost of tranexamic acid (TXA) versus placebo on perioperative blood transfusion in patients undergoing liver resection</measure>
    <time_frame>90 days</time_frame>
    <description>Economic analysis will assess impact of TXA incorporation on health care resources and strategies for systematic utilization of TXA. The analysis will be using data collected in the randomized controlled trial from a societal perspective.The output of the economic analysis is the incremental cost of TXA compared to placebo (control group).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1386</enrollment>
  <condition>Cancer</condition>
  <condition>Tumour</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Tranexamic acid (TXA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline (0.9% sodium chloride)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 g saline bolus injection + 1 g saline infusion from induction over 8 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid (TXA)</intervention_name>
    <description>1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours</description>
    <arm_group_label>Tranexamic acid (TXA)</arm_group_label>
    <other_name>Cyklokapron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>1 g saline bolus injection + 1 g saline infusion from induction over 8 hours</description>
    <arm_group_label>Normal saline (0.9% sodium chloride)</arm_group_label>
    <other_name>0.9% sodium chloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient scheduled for open or laparoscopic liver surgery&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Cancer related diagnosis or indication (e.g. pre-cancer, suspicion of cancer, definite&#xD;
             cancer)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe anemia (hemoglobin (Hgb) levels &lt;90 g/l)&#xD;
&#xD;
          -  Documented arterial or venous thrombosis at screening or in past three months (not&#xD;
             including therapeutic portal vein embolization)&#xD;
&#xD;
          -  Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in&#xD;
             prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or&#xD;
             thrombolytic therapy administered or completed within last week&#xD;
&#xD;
          -  Known disseminated intravascular coagulation&#xD;
&#xD;
          -  Severe renal insufficiency (creatinine clearance (CrCl) &lt;30 ml/min)&#xD;
&#xD;
          -  History of seizure disorder&#xD;
&#xD;
          -  Pregnant or lactating (a negative urine pregnancy test must be obtained for women of&#xD;
             child bearing potential during the pretreatment evaluation)&#xD;
&#xD;
          -  Acquired disturbance of colour vision&#xD;
&#xD;
          -  Hypersensitivity to TXA or any of the ingredients&#xD;
&#xD;
          -  Unable to receive blood products (i.e. difficulty with cross matching, refuses blood&#xD;
             transfusion, or a past history of unexplained severe transfusion reaction)&#xD;
&#xD;
          -  Previously enrolled in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Karanicolas, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Hospital</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kelowna General Hospital</name>
      <address>
        <city>Kelowna</city>
        <state>British Colombia</state>
        <zip>V1Y 1T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2YR</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 8E7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston General Health Research Institute</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6R 1B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood transfusion</keyword>
  <keyword>blood loss</keyword>
  <keyword>feasibility</keyword>
  <keyword>outcome</keyword>
  <keyword>liver resection</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/NCT02261415
org study id: 244-2014
nct id: NCT02261415
lead sponsor: 
collaborator: 
has dmc: No
This is a Phase III multicentre randomized controlled trial (RCT) to evaluate the impact of
      tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing liver
      resection. The rationale for this study includes: (1) experimental evidence supporting the
      use of TXA in other surgical populations; (2) lack of evidence in patients undergoing liver
      resection; (3) clinical uncertainty and extensive support amongst hepatobiliary surgeons,
      anaesthesiologists, and hematologists for this proposed trial; (4) a feasible and efficient
      study design; and (5) the importance of the question: incidence of blood transfusion in
      patients undergoing liver resection is high, and the consequences serious. The sample size
      for this study is 1230 participants.Participants enrolled in the prior Vanguard study will
      proceed directly into the RCT.
Purpose Compelling biological rationale and indirect evidence from other settings suggest
      that there is potential benefit to administering TXA to patients undergoing liver resection.
      A lack of consensus in the hepatobiliary community and lack of direct evidence in patients
      undergoing liver resection mandate a RCT.

      Hypothesis To determine the impact of perioperative administration of TXA to patients
      undergoing liver resection on the need for blood transfusion and long-term survival.

      Justification If TXA use in liver resection resulted in an important decrease in blood
      transfusions, clinical practice worldwide would be likely to change. Over 2000 patients in
      Canada undergo liver resection annually and could benefit from this simple, low-cost
      intervention. This intervention could easily be implemented in other countries, where many
      more patients undergo liver resection annually. Furthermore, TXA may be beneficial in other
      operative fields where bleeding is a major problem, including thoracic surgery, colorectal
      surgery, and many others.

      Objectives

      The primary outcome of the RCT will be:

      1) Receipt of blood transfusion (% transfused): 7 days

      The secondary outcomes of the RCT are:

        1. Intraoperative blood loss will be assessed by adding the net weight of sponges and fluid
           suction (minus irrigation and intraoperative bile or other fluids in suction/sponge)

        2. Total blood loss (postoperative day (POD)0 - POD7) will be assessed by Gross' formula,
           which uses the maximum postoperative decrease in the level of hemoglobin adjusted for
           the weight and height of the patient

        3. Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)

        4. Postoperative incidence of symptomatic venous thromboembolic event confirmed with either
           computed tomography (CT) angiogram (for pulmonary embolism) or venous Doppler ultrasound
           (for deep venous thrombosis) (within 90 days of surgery)

        5. Postoperative complications (within 90 days of surgery) will be determined using the
           Clavien-Dindo classification

        6. Recurrence free survival (within 5 years of surgery) will be determined by review of
           patient medical record every 6 months until 5 years post-surgery

           a. Recurrence free survival is defined as the time from POD0 to the first event that is
           recurrent (local or distal) cancer or death (from any cause)

        7. Overall survival (within 5 years of surgery) will be determined by review of patient
           medical record every 6 months until 5 years post-surgery

           a. Overall survival is defined as the time from date of POD0 to death from any cause

        8. QOL will be determined by administering European Organization for Research and Treatment
           of Cancer (EORTC) Quality of Life Questionnaire (QLQ) -C30 and the QLQ- Liver Metastases
           Colorectal (LMC) 21 at baseline, 30 and 90 days following surgery

        9. Perioperative mortality will be recorded between POD0 and POD7

       10. Economic analysis will assess impact of TXA incorporation on health care resources and
           strategies for systematic utilization of TXA

      Research Method This is a Phase III multicentre randomized controlled trial (RCT) to evaluate
      the impact of tranexamic acid (TXA) on perioperative blood transfusion in patients undergoing
      liver resection. The trial will conceal allocation, maximize possible blinding, independently
      assess the appropriateness of transfusion, use strategies to limit loss to follow-up and
      crossovers, and use a conservative stopping rule. Patients will be administered a single dose
      of study drug intravenously immediately after induction of anaesthesia, followed by infusion
      over eight hours.

      Statistical Analysis Primary analysis will include only patients who underwent liver
      resection; patients who are randomized but do not receive liver resection (usually due to
      more advanced disease identified intraoperatively) will be excluded. A sensitivity analysis
      will be conducted whereby all randomized patients are included in the assessment of the
      primary outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Receipt of blood transfusion (% transfused): 7 days
time frame: 7 days
description: Receipt of one or more RBC transfusions between Day 0 and Day 7
measure: Intraoperative blood loss
time frame: 7 days
description: Intraoperative blood loss will be assessed by adding the net weight of sponges and fluid suction (minus irrigation and intraoperative bile or other fluids in suction/sponge)
measure: Total blood loss
time frame: 7 days
description: Total blood loss (postoperative day (POD)0 - POD7) will be assessed by Gross' formula, which uses the maximum postoperative decrease in the level of hemoglobin adjusted for the weight and height of the patient
measure: Number of packed red blood cells (PRBC) units transfused
time frame: 7 days
description: Number of packed red blood cells (PRBC) units transfused (POD0 - POD7)
measure: Postoperative incidence of symptomatic venous thromboembolic event
time frame: 90 days
description: Postoperative incidence of symptomatic venous thromboembolic event confirmed with either computed tomography (CT) angiogram (for pulmonary embolism) or venous Doppler ultrasound (for deep venous thrombosis) (within 90 days of surgery)
measure: Postoperative complications assessed using Clavien-Dindo Grading System
time frame: 90 days
description: Postoperative complications (within 90 days of surgery) will be determined using the Clavien-Dindo classification
measure: Recurrence Free Survival (within 5 years of surgery)
time frame: 60 months
description: Disease recurrence is defined as the clinical presence of cancer that has either been confirmed by biopsy, has had treatment initiated, or is documented in the treating physician's notes. Five year disease recurrence from day of surgery will be evaluated approximately every 6 months until 5 years via medical record review.
measure: Overall Survival (within 5 years of surgery)
time frame: 60 months
description: Overall survival is defined as the time from date of surgery to death from any cause. It will be determined by review of patient medical record every 6 months until 5 years post-surgery.
measure: Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
time frame: Baseline, 30 days, 90 days
description: QOL will be determined by administering the EORTC QLQ-C30 at baseline, 30 and 90 days following surgery.
measure: Quality of Life (QOL) Assessment using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Liver Module (LM)C21 Questionnaire
time frame: Baseline, 30 days, 90 days
description: QOL will be determined by administering QLQ-LMC21 at baseline, 30 and 90 days following surgery.
measure: Perioperative mortality
time frame: 7 days
description: Perioperative mortality will be recorded between POD0 and POD7
measure: Compare the cost of tranexamic acid (TXA) versus placebo on perioperative blood transfusion in patients undergoing liver resection
time frame: 90 days
description: Economic analysis will assess impact of TXA incorporation on health care resources and strategies for systematic utilization of TXA. The analysis will be using data collected in the randomized controlled trial from a societal perspective.The output of the economic analysis is the incremental cost of TXA compared to placebo (control group).
arm group label: Tranexamic acid (TXA)
arm group type: Experimental
description: 1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
arm group label: Normal saline (0.9% sodium chloride)
arm group type: Placebo Comparator
description: 1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
intervention type: Drug
intervention name: Tranexamic acid (TXA)
description: 1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
arm group label: Tranexamic acid (TXA)
other name: Cyklokapron
intervention type: Drug
intervention name: Normal saline
description: 1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
arm group label: Normal saline (0.9% sodium chloride)
other name: 0.9% sodium chloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul Karanicolas, MD PhD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Tranexamic Acid
sharing ipd: No