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/NCT06014320</url>
    </required_header>
    <id_info>
      <org_study_id>71275</org_study_id>
      <nct_id>NCT06014320</nct_id>
    </id_info>
    <brief_title>Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease</brief_title>
    <official_title>Understanding the Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Stanford University</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 goal of this observational study is to learn about the changes in coagulation factor VIII&#xD;
        and IX levels in patients undergoing liver transplantation to help guide future management of&#xD;
        coagulation factor replacement in patients with hemophilia and liver disease. The question we&#xD;
        aim to answer is: should the recommendations for factor replacement in patients with&#xD;
        hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis?&#xD;
  &#xD;
        Participants will be asked to provide two blood samples, one at the beginning of their liver&#xD;
        transplant, and one after their liver transplant.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Current guidelines for management of hemophilia B suggest replacement of factor IX to 100%&#xD;
        prior to major abdominal surgery. However, in patients with concurrent liver cirrhosis where&#xD;
        the liver does not produce Factor IX, is it worth considering adjusting the factor&#xD;
        replacement strategy? We recently had a case of a patient with Hemophilia B and end-stage&#xD;
        liver disease (ESLD) who underwent orthotopic liver transplantation and received the standard&#xD;
        pre-operative recombinant factor IX replacement. His case was complicated by intra-cardiac&#xD;
        thrombus and hypotension. We conduct a small study to assess the pre-operative&#xD;
        thromboelastography (TEG) and factor levels in ESLD patient which we hope will help guide&#xD;
        clinical decision making in future hemophilia B patients with cirrhosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2024</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Factor VIII level</measure>
      <time_frame>12 hours</time_frame>
      <description>We will collect Factor VIII level pre- and post- transplant</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Factor IX level</measure>
      <time_frame>12 hours</time_frame>
      <description>We will collect Factor IX level pre- and post- transplant</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Thromboelastography (TEG) values</measure>
      <time_frame>12 hours</time_frame>
      <description>We will collect thromboelastography values pre- and post- transplant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Complications</measure>
      <time_frame>24 hours</time_frame>
      <description>We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Liver Cirrhosis</condition>
    <condition>Hemophilia</condition>
    <condition>Hemophilia A</condition>
    <condition>Hemophilia B</condition>
    <condition>Liver Transplant Disorder</condition>
    <condition>Liver Failure</condition>
    <condition>Coagulation Factor Deficiency</condition>
    <arm_group>
      <arm_group_label>ESLD</arm_group_label>
      <description>All participants recruited will belong to this group. These participants will all have end stage liver disease and be listed for liver transplant with an accepted organ offer.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Participants will be recruited for the study who have end stage liver disease and are&#xD;
          undergoing liver transplant at Stanford hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  participants who have end stage liver disease who are listed for liver transplantation&#xD;
               and have an accepted organ offer&#xD;
  &#xD;
            -  age &gt; 18+&#xD;
  &#xD;
            -  MELD &gt; 25&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  undergoing multi-organ transplant&#xD;
  &#xD;
            -  tumor MELD exception points&#xD;
  &#xD;
            -  has hereditary coagulation disease&#xD;
  &#xD;
            -  currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin,&#xD;
               plavix, warfarin, heparin)&#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>Alexandra Ruan, MD</last_name>
      <role>Study Director</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Martin Angst, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexandra Ruan, MD</last_name>
      <phone>650-723-4000</phone>
      <email>aruan@stanford.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Stanford Hospital</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Alonso Madrigal C, Dobon Rebollo M, Laredo de la Torre V, Palomera Bernal L, Garcia Gil FA. Liver transplantation in hemophilia A and von Willebrand disease type 3: perioperative management and post-transplant outcome. Rev Esp Enferm Dig. 2018 Aug;110(8):522-526. doi: 10.17235/reed.2018.5204/2017.</citation>
      <PMID>29931985</PMID>
    </reference>
    <reference>
      <citation>Togashi J, Akamatsu N, Tanaka T, Sugawara Y, Tsukada K, Kaneko J, Arita J, Sakamoto Y, Hasegawa K, Kokudo N. Living donor liver transplantation for hemophilia with special reference to the management of perioperative clotting factor replacement. Liver Transpl. 2016 Mar;22(3):366-70. doi: 10.1002/lt.24341. Epub 2016 Feb 15. No abstract available.</citation>
      <PMID>26390184</PMID>
    </reference>
    <reference>
      <citation>Kadry Z, de Moerloose P, Giostra E, Morel P, Huber O, Meili E, Blum HE, Mentha G. Orthotopic liver transplantation in hemophilia B: a case report. Transpl Int. 1995;8(6):485-7. doi: 10.1007/BF00335602.</citation>
      <PMID>8579741</PMID>
    </reference>
    <results_reference>
      <citation>Ramiz S, Hartmann J, Young G, Escobar MA, Chitlur M. Clinical utility of viscoelastic testing (TEG and ROTEM analyzers) in the management of old and new therapies for hemophilia. Am J Hematol. 2019 Feb;94(2):249-256. doi: 10.1002/ajh.25319. Epub 2018 Dec 7.</citation>
      <PMID>30328141</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Alexandra Ruan</investigator_full_name>
      <investigator_title>Clinical Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>liver transplant</keyword>
    <keyword>hemophilia</keyword>
    <keyword>coagulation</keyword>
    <keyword>thrombosis</keyword>
    <keyword>bleeding</keyword>
    <keyword>cirrhosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Cirrhosis</mesh_term>
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Liver Failure</mesh_term>
      <mesh_term>End Stage Liver Disease</mesh_term>
      <mesh_term>Hemophilia A</mesh_term>
      <mesh_term>Hemophilia B</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_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/NCT06014320
  org study id: 71275
  nct id: NCT06014320
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the changes in coagulation factor VIII
        and IX levels in patients undergoing liver transplantation to help guide future management of
        coagulation factor replacement in patients with hemophilia and liver disease. The question we
        aim to answer is: should the recommendations for factor replacement in patients with
        hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis?
  
        Participants will be asked to provide two blood samples, one at the beginning of their liver
        transplant, and one after their liver transplant.
  Current guidelines for management of hemophilia B suggest replacement of factor IX to 100%
        prior to major abdominal surgery. However, in patients with concurrent liver cirrhosis where
        the liver does not produce Factor IX, is it worth considering adjusting the factor
        replacement strategy? We recently had a case of a patient with Hemophilia B and end-stage
        liver disease (ESLD) who underwent orthotopic liver transplantation and received the standard
        pre-operative recombinant factor IX replacement. His case was complicated by intra-cardiac
        thrombus and hypotension. We conduct a small study to assess the pre-operative
        thromboelastography (TEG) and factor levels in ESLD patient which we hope will help guide
        clinical decision making in future hemophilia B patients with cirrhosis.
  observational model: Cohort
  time perspective: Prospective
  measure: Factor VIII level
  time frame: 12 hours
  description: We will collect Factor VIII level pre- and post- transplant
  measure: Factor IX level
  time frame: 12 hours
  description: We will collect Factor IX level pre- and post- transplant
  measure: Thromboelastography (TEG) values
  time frame: 12 hours
  description: We will collect thromboelastography values pre- and post- transplant
  measure: Complications
  time frame: 24 hours
  description: We will collect data on bleeding or clotting events during the liver transplant surgery and 24 hours post-operatively
  arm group label: ESLD
  description: All participants recruited will belong to this group. These participants will all have end stage liver disease and be listed for liver transplant with an accepted organ offer.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexandra Ruan, MD
  role: Study Director
  affiliation: Stanford University
  last name: Martin Angst, MD
  role: Principal Investigator
  affiliation: Stanford University
  last name: Alexandra Ruan, MD
  phone: 650-723-4000
  email: aruan@stanford.edu
  facility: 
  country: United States
  citation: Alonso Madrigal C, Dobon Rebollo M, Laredo de la Torre V, Palomera Bernal L, Garcia Gil FA. Liver transplantation in hemophilia A and von Willebrand disease type 3: perioperative management and post-transplant outcome. Rev Esp Enferm Dig. 2018 Aug;110(8):522-526. doi: 10.17235/reed.2018.5204/2017.
  PMID: 29931985
  citation: Togashi J, Akamatsu N, Tanaka T, Sugawara Y, Tsukada K, Kaneko J, Arita J, Sakamoto Y, Hasegawa K, Kokudo N. Living donor liver transplantation for hemophilia with special reference to the management of perioperative clotting factor replacement. Liver Transpl. 2016 Mar;22(3):366-70. doi: 10.1002/lt.24341. Epub 2016 Feb 15. No abstract available.
  PMID: 26390184
  citation: Kadry Z, de Moerloose P, Giostra E, Morel P, Huber O, Meili E, Blum HE, Mentha G. Orthotopic liver transplantation in hemophilia B: a case report. Transpl Int. 1995;8(6):485-7. doi: 10.1007/BF00335602.
  PMID: 8579741
  citation: Ramiz S, Hartmann J, Young G, Escobar MA, Chitlur M. Clinical utility of viscoelastic testing (TEG and ROTEM analyzers) in the management of old and new therapies for hemophilia. Am J Hematol. 2019 Feb;94(2):249-256. doi: 10.1002/ajh.25319. Epub 2018 Dec 7.
  PMID: 30328141
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Alexandra Ruan
  investigator title: Clinical Assistant Professor
  mesh term: Liver Cirrhosis
  mesh term: Liver Diseases
  mesh term: Liver Failure
  mesh term: End Stage Liver Disease
  mesh term: Hemophilia A
  mesh term: Hemophilia B
  mesh term: Fibrosis
  sharing ipd: No