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/NCT05966012</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 323740</org_study_id>
      <nct_id>NCT05966012</nct_id>
    </id_info>
    <brief_title>Tranexamic Acid Dose and Confusion After Cardiac Surgery</brief_title>
    <official_title>Are Higher Doses of Tranexamic Acid Associated With a Lower Incidence of Post-operative Delirium After Cardiac Surgery? A Retrospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Papworth Hospital NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Papworth Hospital NHS Foundation Trust</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>
        Delirium is one of the most common complications after cardiac surgery and occurs with an&#xD;
        incidence of 3 - 70%.&#xD;
  &#xD;
        Both predisposing factors (age, diabetes, severity of cardiac disease, atrial fibrillation)&#xD;
        and precipitating factors (type of surgery, duration of cardiopulmonary bypass (CPB) and&#xD;
        surgery, ventilator time in ICU, highest temperature in intensive care (ICU)) are difficult&#xD;
        to influence. Post-operative delirium is a devastating complication, leading to longer ICU&#xD;
        and hospital stay, increased incidence of discharge to nursing facility and poorer long-term&#xD;
        cognitive outcome.&#xD;
  &#xD;
        Despite the impact this complication has on individuals, their families and healthcare&#xD;
        resources, little is known about the causes and potential preventative measures.&#xD;
  &#xD;
        It is thought that systemic inflammation compromising the integrity of the blood brain&#xD;
        barrier is an important contributing factor. Recent data suggests that antifibrinolytics like&#xD;
        tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused&#xD;
        by surgery and CPB through the inhibition of plasmin production, thereby stabilising the&#xD;
        blood brain barrier. Worldwide, the use of TXA has become standard of care in cardiac surgery&#xD;
        and other types of surgery with a high risk of bleeding. It has been shown to reduce bleeding&#xD;
        by 25% and significantly reduce the rate of transfusion in cardiac and noncardiac surgery.&#xD;
  &#xD;
        At Royal Papworth hospital it is routine practice to administer 2g of TXA before commencing&#xD;
        CPB irrespective of patients' body weight. We are hypothesising that there is a weight-based&#xD;
        effect of TXA on neurological outcomes after cardiac surgery, showing a signal that a higher&#xD;
        dose per kg bodyweight will lead to less delirium measured with the Richmond&#xD;
        Agitation-Sedation Score (RASS). We intend to analyse 4 years' worth of patient data (05/2018&#xD;
        - 08/2022); the necessary information is routinely collected on using the hospital&#xD;
        anaesthetic and ICU record.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        There will be no patient contact at any point of this retrospective analysis. The data&#xD;
        collected will have been routinely collected on the hospital's electronic systems as part of&#xD;
        routine clinical care and data collection.&#xD;
  &#xD;
        This is a very new field of interest in cardiac anaesthesia / surgery. No clinical data is&#xD;
        currently available apart from recent preliminary data suggesting that Tranexamic Acid (TXA)&#xD;
        improves the inflammatory reaction the nervous system has to surgery and cardiopulmonary&#xD;
        bypass. The first trial in this area, a RCT (TXA vs no TXA) in abdominal surgery, has only&#xD;
        just started recruiting (Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery:&#xD;
        the TRIGS-D Trial; clinicaltrials.gov).&#xD;
  &#xD;
        The statistical methods will be determined once data distribution is known; the&#xD;
        interdependence of primary and secondary outcome measures will be determined by multivariate&#xD;
        regression analysis.&#xD;
  &#xD;
        At this stage it is not possible to devise a prospective randomised controlled trial similar&#xD;
        the TRIGS-D study in cardiac surgery as giving TXA is considered standard of care. It might&#xD;
        be possible, however, to design a RCT comparing different TXA dosing regimens once the the&#xD;
        results of this retrospective analysis are available.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Richmond Agitation Sedation Score</measure>
      <time_frame>Up to 48hours after surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>30 day mortality</measure>
      <time_frame>Up to 30 days after surgery</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Cardiovascular Surgery</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tranexamic acid</intervention_name>
      <description>Recent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018&#xD;
          and 08/2022&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          All patients undergoing elective or in-house urgent cardiac surgery at RPH between 05/2018&#xD;
          and 08/2022&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients undergoing&#xD;
  &#xD;
            -  operations involving deep hypothermic circulatory arrest,&#xD;
  &#xD;
            -  operations involving thoracic vessels other than the ascending aorta,&#xD;
  &#xD;
            -  solid organ transplantation or mechanical assist device implantation,&#xD;
  &#xD;
            -  emergency operations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Royal Papworth Hospital NHS Foundation Trust</name>
        <address>
          <city>Cambridge</city>
          <state>Cambridgeshire</state>
          <zip>CB23 3RE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
  
  
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/NCT05966012
  org study id: IRAS 323740
  nct id: NCT05966012
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Delirium is one of the most common complications after cardiac surgery and occurs with an
        incidence of 3 - 70%.
  
        Both predisposing factors (age, diabetes, severity of cardiac disease, atrial fibrillation)
        and precipitating factors (type of surgery, duration of cardiopulmonary bypass (CPB) and
        surgery, ventilator time in ICU, highest temperature in intensive care (ICU)) are difficult
        to influence. Post-operative delirium is a devastating complication, leading to longer ICU
        and hospital stay, increased incidence of discharge to nursing facility and poorer long-term
        cognitive outcome.
  
        Despite the impact this complication has on individuals, their families and healthcare
        resources, little is known about the causes and potential preventative measures.
  
        It is thought that systemic inflammation compromising the integrity of the blood brain
        barrier is an important contributing factor. Recent data suggests that antifibrinolytics like
        tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused
        by surgery and CPB through the inhibition of plasmin production, thereby stabilising the
        blood brain barrier. Worldwide, the use of TXA has become standard of care in cardiac surgery
        and other types of surgery with a high risk of bleeding. It has been shown to reduce bleeding
        by 25% and significantly reduce the rate of transfusion in cardiac and noncardiac surgery.
  
        At Royal Papworth hospital it is routine practice to administer 2g of TXA before commencing
        CPB irrespective of patients' body weight. We are hypothesising that there is a weight-based
        effect of TXA on neurological outcomes after cardiac surgery, showing a signal that a higher
        dose per kg bodyweight will lead to less delirium measured with the Richmond
        Agitation-Sedation Score (RASS). We intend to analyse 4 years' worth of patient data (05/2018
        - 08/2022); the necessary information is routinely collected on using the hospital
        anaesthetic and ICU record.
  There will be no patient contact at any point of this retrospective analysis. The data
        collected will have been routinely collected on the hospital's electronic systems as part of
        routine clinical care and data collection.
  
        This is a very new field of interest in cardiac anaesthesia / surgery. No clinical data is
        currently available apart from recent preliminary data suggesting that Tranexamic Acid (TXA)
        improves the inflammatory reaction the nervous system has to surgery and cardiopulmonary
        bypass. The first trial in this area, a RCT (TXA vs no TXA) in abdominal surgery, has only
        just started recruiting (Tranexamic Acid to Reduce Delirium After Gastrointestinal Surgery:
        the TRIGS-D Trial; clinicaltrials.gov).
  
        The statistical methods will be determined once data distribution is known; the
        interdependence of primary and secondary outcome measures will be determined by multivariate
        regression analysis.
  
        At this stage it is not possible to devise a prospective randomised controlled trial similar
        the TRIGS-D study in cardiac surgery as giving TXA is considered standard of care. It might
        be possible, however, to design a RCT comparing different TXA dosing regimens once the the
        results of this retrospective analysis are available.
  observational model: Cohort
  time perspective: Retrospective
  measure: Richmond Agitation Sedation Score
  time frame: Up to 48hours after surgery
  measure: 30 day mortality
  time frame: Up to 30 days after surgery
  intervention type: Drug
  intervention name: Tranexamic acid
  description: Recent data suggests that antifibrinolytics like tranexamic acid (TXA) might be able to lessen the inflammation of the nervous system caused by surgery and CPB through the inhibition of plasmin production, thereby stabilising the blood brain barrier.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Tranexamic Acid
  sharing ipd: No