<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/NCT04489108</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-34</org_study_id>
    <nct_id>NCT04489108</nct_id>
  </id_info>
  <brief_title>Tranexamic Acid for Acute Upper Gastrointestinal Bleed in Cirrhosis</brief_title>
  <official_title>Tranexamic Acid for Acute Upper Gastrointestinal Bleed in Cirrhosis - A Randomized Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients&#xD;
      with cirrhosis, as it is responsible for severe complications and high mortality rates.&#xD;
      Fibrinolytic activity of the epithelial surfaces and of the submucosal blood vessels may&#xD;
      interfere with hematemesis and even delay healing of ulcers. Tranexamic acid (TXA) may help&#xD;
      control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is&#xD;
      a lack of unbiased data to conclude on its efficacy. Tranexamic Acid in patients with acute&#xD;
      Upper Gastrointestinal bleed have been shown to prevent re bleed in few studies when combined&#xD;
      with standard medical management (which generally comprises of initial fluid resuscitation,&#xD;
      intravenous PPI , splanchnic vasoconstrictors, blood transfusions and coagulopathy&#xD;
      corrections as per lab parameters) but no randomized placebo controlled trial has been done.&#xD;
      The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB&#xD;
      as compared to placebo in patients with cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim and Objective - AIM- To compare the efficacy and safety of tranexamic acid in reducing&#xD;
      5-day treatment failure (i.e., failure to control bleed) in patients with cirrhosis&#xD;
      presenting with Upper GI bleed&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      Proportion of patients developing five-day treatment failure (i.e., failure to control bleed)&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        1. Failure to prevent rebleed within 6 weeks&#xD;
&#xD;
        2. Clinically significant rebleed within 6 weeks (monitored by hemoglobin drop by 3g/dl,&#xD;
           need of blood transfusion)&#xD;
&#xD;
        3. Need for salvage therapy (tamponade, additional endoscopic therapy, TIPS, surgery etc.)&#xD;
&#xD;
        4. Blood product and component requirements&#xD;
&#xD;
        5. Days of ICU/hospital stay&#xD;
&#xD;
        6. Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial&#xD;
           infarction etc)&#xD;
&#xD;
        7. Other complications post bleed (including other significant cardiac event, sepsis,&#xD;
           pneumonia, respiratory failure, Acute Kidney Injury, seizures etc)&#xD;
&#xD;
        8. Mortality attributed to failure to control bleed.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
        -  Study population: Patients of Cirrhosis presenting with Acute Upper Gastrointestinal&#xD;
           bleed&#xD;
&#xD;
        -  Study design:Single Centre, Double Blinded (Patient and Treating physician), Placebo&#xD;
           Controlled (Saline), Randomised Controlled Trial&#xD;
&#xD;
        -  Study period: 1.5 years from the date of ethics approval&#xD;
&#xD;
      Sample size with justification:&#xD;
&#xD;
      - Assuming 5-day treatment failure in Placebo arm around 25% and 15 % in the treatment arm.&#xD;
      Alpha- 5%, Power- 80%. The investigators need to enroll 542 cases with 271 in each group.&#xD;
      Further assuming 10% dropout, it is decided to enroll 600 cases , randomly allocated into two&#xD;
      arms by Block Randomization with Block size of 10. An interim analysis will be done at&#xD;
      reaching total of 300 sample size.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      - Patients will be randomized into two Arms A &amp; B. Both the patient and treating physician&#xD;
      are blinded Arm A- Tranexamic Acid arm- Will receive Tranexamic Acid 1g iv bolus as loading&#xD;
      dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical&#xD;
      and interventional (Endoscopy) therapy.&#xD;
&#xD;
      Arm B- Will receive similar volume of isotonic solution (saline) along with standard medical&#xD;
      and interventional (Endoscopy) therapy.&#xD;
&#xD;
      Monitoring and Assessment:&#xD;
&#xD;
        1. Five-day treatment failure (i.e., failure to control bleed)- defined as death or need to&#xD;
           change therapy defined by one of the following criteria:&#xD;
&#xD;
             -  fresh hematemesis or&#xD;
&#xD;
             -  nasogastric aspiration of ≥100 mL of fresh blood ≥2 hours after the start of a&#xD;
                specific drug treatment or&#xD;
&#xD;
             -  therapeutic endoscopy;&#xD;
&#xD;
             -  development of hypovolaemic shock;&#xD;
&#xD;
             -  3 g drop in hemoglobin (Hb) (9% drop of hematocrit) within any 24-hour period if no&#xD;
                transfusion is administered.&#xD;
&#xD;
        2. Failure to prevent rebleeding defined as a single episode of clinically significant&#xD;
           rebleeding after day 5 until 6 weeks, and&#xD;
&#xD;
        3. Clinically significant rebleeding defined as recurrent melena or hematemesis resulting&#xD;
           in any of the following after day 5 until 6 weeks:&#xD;
&#xD;
             -  hospital admission,&#xD;
&#xD;
             -  blood transfusion,&#xD;
&#xD;
             -  3 g drop in haemoglobin, or&#xD;
&#xD;
             -  Death&#xD;
&#xD;
      Other treatments given&#xD;
&#xD;
        1. Conditioning (intravenous access, tracheal intubation or other airways management&#xD;
           technique if needed)&#xD;
&#xD;
        2. Medical interventions (immediate splanchnic vasopressors: terlipressin or somatostatin&#xD;
           and derivatives before endoscopy (up to 5 days)&#xD;
&#xD;
        3. PPIs in case of suspicion of associated peptic ulcer&#xD;
&#xD;
        4. Antibiotics during 5 days and later as needed&#xD;
&#xD;
        5. Hemodynamic stabilisation (fluid infusion, systemic vasopressors as noradrenalin or&#xD;
           adrenalin);&#xD;
&#xD;
        6. Technical interventions (endoscopy as soon as possible, within 12 hours, and haemostatic&#xD;
           interventions like EVL, Glue, Dannis-Ella stent, if feasible early TIPS within 72 hours&#xD;
           (Child C or B with active bleeding at endoscopy)&#xD;
&#xD;
        7. Secondary prophylaxis (from day 6 after onset): beta blockers if stable will be&#xD;
           mandatory for the secondary prophylaxis.&#xD;
&#xD;
        8. ROTEM based correction will be given for patients having nonvariceal upper GI bleeding&#xD;
           (diagnosed after doing upper GI endoscopy and showing ongoing bleed form a nonvariceal&#xD;
           source at that time); and significant coagulopathy assessed by INR &gt; 1.8 and/or PLTs &lt;&#xD;
           50 × 109/L.&#xD;
&#xD;
      Assessment of Fibrinolysis:&#xD;
&#xD;
        1. FDP (Fibrin Degradation Products)&#xD;
&#xD;
        2. d-Dimer assay&#xD;
&#xD;
        3. Fibrinogen&#xD;
&#xD;
        4. FIBTEM-EXTEM&#xD;
&#xD;
      Data to be Collected&#xD;
&#xD;
        1. Hemogram, PT/INR, LFT, KFT (baseline, D1, 3, 5, 7, 14, 28, 42 and as needed)&#xD;
&#xD;
        2. d-Dimer, FDP, Fibrinogen, ROTEM (FIBTEM/EXTEM): (baseline, day 1, 3, 5)&#xD;
&#xD;
        3. USG with doppler SPA, AFP, sugar (F),Chest Xray other etiological investigations as&#xD;
           needed: baseline&#xD;
&#xD;
        4. UGIE findings&#xD;
&#xD;
        5. Other clinical parameters such as CTP score, MELD score, Heart rate, Blood Pressure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 5, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2022</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients developing five-day treatment failure in both the groups</measure>
    <time_frame>5 day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with failure to prevent rebleed in both group</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically significant rebleed in both groups</measure>
    <time_frame>6 weeks</time_frame>
    <description>Clinically significant rebleed as monitored by hemoglobin drop by 3g/dl, need of blood transfusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will require salvage therapy in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who will require Blood product and component in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days in Intensive Care Unit in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days in hospital in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with deep vein thrombosis in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with pulmonary embolism in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with stroke in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with myocardial infarction in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Adverse Events associated with post bleed in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with Mortality attributed to failure to control bleed in both groups</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Tranexamic Acid with Standard Medical Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A will Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical and interventional (Endoscopy) therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Standard Medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm B will receive similar volume of isotonic solution (saline) along with standard medical and interventional (Endoscopy) therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tranexamic acid</intervention_name>
    <description>Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours</description>
    <arm_group_label>Tranexamic Acid with Standard Medical Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Medical Treatment</intervention_name>
    <description>Standard Medical Treatment</description>
    <arm_group_label>Placebo + Standard Medical treatment</arm_group_label>
    <arm_group_label>Tranexamic Acid with Standard Medical Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>isotonic solution (saline)</description>
    <arm_group_label>Placebo + Standard Medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients greater than 18 years of age&#xD;
&#xD;
          2. Presenting with Acute UGI bleed (&lt; 24hrs from onset).&#xD;
&#xD;
          3. Cirrhosis (Known Or suspected on clinical, biological, radiological data or the&#xD;
             patient's history) with CTP B / C (i.e. CTP &gt;/=7) or ACLF (with clinical evidence of&#xD;
             cirrhosis).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non cirrhotic patients&#xD;
&#xD;
          2. Known allergy to Tranexamic Acid&#xD;
&#xD;
          3. Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like&#xD;
             coagulopathy patches/ haematuria / uncontrolled epistaxis etc.&#xD;
&#xD;
          4. Patients with Chronic Kidney Disease.&#xD;
&#xD;
          5. History of recent Cerebro Vascular Accident (CVA) [in the past 6 months] or patients&#xD;
             with thrombotic events [Portal Vein thrombosis /Hepatic vein thrombosis /other sites&#xD;
             thrombosis]. HCC with tumour thrombosis will be included&#xD;
&#xD;
          6. Any history of seizures, myocardial infarction&#xD;
&#xD;
          7. Pregnancy/lactation&#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_contact>
    <last_name>Dr Shantan Venishetty, MD</last_name>
    <phone>01146300000</phone>
    <email>venishantan@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr Shantan Venishetty, MD</last_name>
      <phone>01146300000</phone>
      <email>venishantan@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Fibrosis</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>
  </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/NCT04489108
org study id: ILBS-Cirrhosis-34
nct id: NCT04489108
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients
      with cirrhosis, as it is responsible for severe complications and high mortality rates.
      Fibrinolytic activity of the epithelial surfaces and of the submucosal blood vessels may
      interfere with hematemesis and even delay healing of ulcers. Tranexamic acid (TXA) may help
      control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is
      a lack of unbiased data to conclude on its efficacy. Tranexamic Acid in patients with acute
      Upper Gastrointestinal bleed have been shown to prevent re bleed in few studies when combined
      with standard medical management (which generally comprises of initial fluid resuscitation,
      intravenous PPI , splanchnic vasoconstrictors, blood transfusions and coagulopathy
      corrections as per lab parameters) but no randomized placebo controlled trial has been done.
      The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB
      as compared to placebo in patients with cirrhosis.
Aim and Objective - AIM- To compare the efficacy and safety of tranexamic acid in reducing
      5-day treatment failure (i.e., failure to control bleed) in patients with cirrhosis
      presenting with Upper GI bleed

      Primary Objective:

      Proportion of patients developing five-day treatment failure (i.e., failure to control bleed)

      Secondary Objectives:

        1. Failure to prevent rebleed within 6 weeks

        2. Clinically significant rebleed within 6 weeks (monitored by hemoglobin drop by 3g/dl,
           need of blood transfusion)

        3. Need for salvage therapy (tamponade, additional endoscopic therapy, TIPS, surgery etc.)

        4. Blood product and component requirements

        5. Days of ICU/hospital stay

        6. Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial
           infarction etc)

        7. Other complications post bleed (including other significant cardiac event, sepsis,
           pneumonia, respiratory failure, Acute Kidney Injury, seizures etc)

        8. Mortality attributed to failure to control bleed.

      Methodology:

        -  Study population: Patients of Cirrhosis presenting with Acute Upper Gastrointestinal
           bleed

        -  Study design:Single Centre, Double Blinded (Patient and Treating physician), Placebo
           Controlled (Saline), Randomised Controlled Trial

        -  Study period: 1.5 years from the date of ethics approval

      Sample size with justification:

      - Assuming 5-day treatment failure in Placebo arm around 25% and 15 % in the treatment arm.
      Alpha- 5%, Power- 80%. The investigators need to enroll 542 cases with 271 in each group.
      Further assuming 10% dropout, it is decided to enroll 600 cases , randomly allocated into two
      arms by Block Randomization with Block size of 10. An interim analysis will be done at
      reaching total of 300 sample size.

      Intervention:

      - Patients will be randomized into two Arms A & B. Both the patient and treating physician
      are blinded Arm A- Tranexamic Acid arm- Will receive Tranexamic Acid 1g iv bolus as loading
      dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical
      and interventional (Endoscopy) therapy.

      Arm B- Will receive similar volume of isotonic solution (saline) along with standard medical
      and interventional (Endoscopy) therapy.

      Monitoring and Assessment:

        1. Five-day treatment failure (i.e., failure to control bleed)- defined as death or need to
           change therapy defined by one of the following criteria:

             -  fresh hematemesis or

             -  nasogastric aspiration of ≥100 mL of fresh blood ≥2 hours after the start of a
                specific drug treatment or

             -  therapeutic endoscopy;

             -  development of hypovolaemic shock;

             -  3 g drop in hemoglobin (Hb) (9% drop of hematocrit) within any 24-hour period if no
                transfusion is administered.

        2. Failure to prevent rebleeding defined as a single episode of clinically significant
           rebleeding after day 5 until 6 weeks, and

        3. Clinically significant rebleeding defined as recurrent melena or hematemesis resulting
           in any of the following after day 5 until 6 weeks:

             -  hospital admission,

             -  blood transfusion,

             -  3 g drop in haemoglobin, or

             -  Death

      Other treatments given

        1. Conditioning (intravenous access, tracheal intubation or other airways management
           technique if needed)

        2. Medical interventions (immediate splanchnic vasopressors: terlipressin or somatostatin
           and derivatives before endoscopy (up to 5 days)

        3. PPIs in case of suspicion of associated peptic ulcer

        4. Antibiotics during 5 days and later as needed

        5. Hemodynamic stabilisation (fluid infusion, systemic vasopressors as noradrenalin or
           adrenalin);

        6. Technical interventions (endoscopy as soon as possible, within 12 hours, and haemostatic
           interventions like EVL, Glue, Dannis-Ella stent, if feasible early TIPS within 72 hours
           (Child C or B with active bleeding at endoscopy)

        7. Secondary prophylaxis (from day 6 after onset): beta blockers if stable will be
           mandatory for the secondary prophylaxis.

        8. ROTEM based correction will be given for patients having nonvariceal upper GI bleeding
           (diagnosed after doing upper GI endoscopy and showing ongoing bleed form a nonvariceal
           source at that time); and significant coagulopathy assessed by INR > 1.8 and/or PLTs <
           50 × 109/L.

      Assessment of Fibrinolysis:

        1. FDP (Fibrin Degradation Products)

        2. d-Dimer assay

        3. Fibrinogen

        4. FIBTEM-EXTEM

      Data to be Collected

        1. Hemogram, PT/INR, LFT, KFT (baseline, D1, 3, 5, 7, 14, 28, 42 and as needed)

        2. d-Dimer, FDP, Fibrinogen, ROTEM (FIBTEM/EXTEM): (baseline, day 1, 3, 5)

        3. USG with doppler SPA, AFP, sugar (F),Chest Xray other etiological investigations as
           needed: baseline

        4. UGIE findings

        5. Other clinical parameters such as CTP score, MELD score, Heart rate, Blood Pressure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of patients developing five-day treatment failure in both the groups
time frame: 5 day
measure: Number of patients with failure to prevent rebleed in both group
time frame: 6 weeks
measure: Clinically significant rebleed in both groups
time frame: 6 weeks
description: Clinically significant rebleed as monitored by hemoglobin drop by 3g/dl, need of blood transfusion
measure: Number of patients who will require salvage therapy in both groups
time frame: 6 weeks
measure: Number of patients who will require Blood product and component in both groups
time frame: 6 weeks
measure: Number of days in Intensive Care Unit in both groups
time frame: 6 weeks
measure: Number of days in hospital in both groups
time frame: 6 weeks
measure: Number of patients with deep vein thrombosis in both groups
time frame: 6 weeks
measure: Number of patients with pulmonary embolism in both groups
time frame: 6 weeks
measure: Number of patients with stroke in both groups
time frame: 6 weeks
measure: Number of patients with myocardial infarction in both groups
time frame: 6 weeks
measure: Number of patients with Adverse Events associated with post bleed in both groups
time frame: 6 weeks
measure: Number of patients with Mortality attributed to failure to control bleed in both groups
time frame: 6 weeks
arm group label: Tranexamic Acid with Standard Medical Treatment
arm group type: Experimental
description: Arm A will Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical and interventional (Endoscopy) therapy.
arm group label: Placebo + Standard Medical treatment
arm group type: Active Comparator
description: Arm B will receive similar volume of isotonic solution (saline) along with standard medical and interventional (Endoscopy) therapy.
intervention type: Drug
intervention name: Tranexamic acid
description: Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours
arm group label: Tranexamic Acid with Standard Medical Treatment
intervention type: Other
intervention name: Standard Medical Treatment
description: Standard Medical Treatment
arm group label: Placebo + Standard Medical treatment
arm group label: Tranexamic Acid with Standard Medical Treatment
intervention type: Other
intervention name: Placebo
description: isotonic solution (saline)
arm group label: Placebo + Standard Medical treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Shantan Venishetty, MD
phone: 01146300000
email: venishantan@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Gastrointestinal Hemorrhage
mesh term: Fibrosis
mesh term: Tranexamic Acid
sharing ipd: Undecided