<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/NCT03753880</url>
  </required_header>
  <id_info>
    <org_study_id>MUV 1.0</org_study_id>
    <nct_id>NCT03753880</nct_id>
  </id_info>
  <brief_title>Hemopatch for Prevention of Bile Leaks After Liver Resection</brief_title>
  <official_title>Efficacy of NHS-PEG (Pentaerythirol Polyethylene Glycol Ether Tetra-succinimidyl Glutarate) Coated Collagen Patch (Hemopatch®) for Prevention of Bile Leaks After Liver Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In liver surgery bile leaks are still a major cause of postoperative morbidity with the need&#xD;
      for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality&#xD;
      and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are&#xD;
      therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed&#xD;
      faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the&#xD;
      fibrin-coated collagen patch in an animal model. This might be attributed to an improved&#xD;
      tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the&#xD;
      hepatic resection surface may also serve as a mechanical sealant of bile ducts thus&#xD;
      preventing biliary leakage.&#xD;
&#xD;
      To date, there exists no study including a sufficient number of patients to clarify whether&#xD;
      sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks&#xD;
      and data regarding the expected difference in the incidence of biliary complications are&#xD;
      lacking.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 23, 2019</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bile leaks</measure>
    <time_frame>30 days</time_frame>
    <description>biliary leak is defined as bilirubin concentration in the abdominal drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>30 days</time_frame>
    <description>Postoperative bleeding that requires surgical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abscess</measure>
    <time_frame>30 days</time_frame>
    <description>Abscess that requires surgical intervention or percutaneous drainage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortalitiy</measure>
    <time_frame>30 days</time_frame>
    <description>Overall mortality within 30 days post liver resection</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">71</enrollment>
  <condition>Bile Leak</condition>
  <arm_group>
    <arm_group_label>Hemopatch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hemopatch used to cover the resection surface after LR</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HEMOPATCH Sealing Hemostat</intervention_name>
    <description>Hemopatch sealing hemostat used after LR to cover the resection surface</description>
    <arm_group_label>Hemopatch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective hepatic resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor atypical hepatectomy without a plain cut surface&#xD;
&#xD;
          -  Contraindications to the application of Hemopatch®&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christoph Schwarz, MD., PhD</last_name>
    <phone>0043(0)1/40400/56210</phone>
    <email>christoph.a.schwarz@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christoph Schwarz, MD., PhD</last_name>
      <phone>0043(0)40400/56210</phone>
      <email>christoph.a.schwarz@meduniwien.ac.at</email>
    </contact>
    <contact_backup>
      <last_name>Klaus Kaczirek, MD.</last_name>
      <phone>0043(0)1/40400/56210</phone>
      <email>klaus.kaczirek@meduniwien.ac.at</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Christoph Schwarz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Liver resection</keyword>
  <keyword>Bile leaks</keyword>
  <keyword>Outcome</keyword>
  <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/NCT03753880
org study id: MUV 1.0
nct id: NCT03753880
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
In liver surgery bile leaks are still a major cause of postoperative morbidity with the need
      for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality
      and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are
      therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed
      faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the
      fibrin-coated collagen patch in an animal model. This might be attributed to an improved
      tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the
      hepatic resection surface may also serve as a mechanical sealant of bile ducts thus
      preventing biliary leakage.

      To date, there exists no study including a sufficient number of patients to clarify whether
      sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks
      and data regarding the expected difference in the incidence of biliary complications are
      lacking.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Bile leaks
time frame: 30 days
description: biliary leak is defined as bilirubin concentration in the abdominal drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3 or as the need for radiologic or operative intervention resulting from biliary collections or biliary peritonitis
measure: Bleeding
time frame: 30 days
description: Postoperative bleeding that requires surgical intervention
measure: Abscess
time frame: 30 days
description: Abscess that requires surgical intervention or percutaneous drainage
measure: Mortalitiy
time frame: 30 days
description: Overall mortality within 30 days post liver resection
arm group label: Hemopatch
arm group type: Experimental
description: Hemopatch used to cover the resection surface after LR
intervention type: Device
intervention name: HEMOPATCH Sealing Hemostat
description: Hemopatch sealing hemostat used after LR to cover the resection surface
arm group label: Hemopatch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Christoph Schwarz, MD., PhD
phone: 0043(0)1/40400/56210
email: christoph.a.schwarz@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
contact backup: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Christoph Schwarz
investigator title: Principal Investigator
sharing ipd: Undecided