<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/NCT01717612</url>
  </required_header>
  <id_info>
    <org_study_id>Thrombin study</org_study_id>
    <nct_id>NCT01717612</nct_id>
  </id_info>
  <brief_title>A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding</brief_title>
  <official_title>A Prospective, Randomized Trial of Histoacryl Injection Versus Thrombin in the Control of Acute Gastric Variceal Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Science Council, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>E-DA Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Science Council, Taiwan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Though histoacryl injection is now regarded as treatment of choice in the control of gastric&#xD;
      variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer&#xD;
      bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On&#xD;
      the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding&#xD;
      gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were&#xD;
      between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without&#xD;
      inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have proven that the use of cyanoacrylate glue injection was superior to EIS&#xD;
      or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue&#xD;
      injection has gained worldwide popularity except the United States. The hemostatic rates of&#xD;
      glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%.&#xD;
&#xD;
      Though histoacryl injection is now regarded as treatment of choice in the control of gastric&#xD;
      variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer&#xD;
      bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On&#xD;
      the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding&#xD;
      gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were&#xD;
      between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without&#xD;
      inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.&#xD;
      The mechanism of hemostasis induced by thrombin is through the conversion of fibrinogen to&#xD;
      fibrin and enhancement of platelets aggregation. This trial aimed to compare the relative&#xD;
      efficacy and safety between histoacryl injection and thrombin injection in the prevention of&#xD;
      gastric variceal rebleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Anticipated">April 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer on gastric varices</measure>
    <time_frame>1 month after therapy</time_frame>
    <description>ulcer crater or ulcer with bleeding from gastric varices</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rebleeding</measure>
    <time_frame>6 weeks</time_frame>
    <description>rebleeding from gastric varices</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Ulcer, on Gastric Varices</condition>
  <condition>Rebleeding From Gastric Varices</condition>
  <arm_group>
    <arm_group_label>Histoacryl group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the injected agents consisted of n-butyl-2-cyanoacrylate (Histoacryl; B.Braun, Melsungen AG, Germany) 0.5ml mixed with 1.5 ml Lipiodol ultra-fluide (Guerbet, Bois Cedex, France). The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>thrombin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thrombin</intervention_name>
    <description>Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)</description>
    <arm_group_label>thrombin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Histoacryl</intervention_name>
    <description>The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.</description>
    <arm_group_label>Histoacryl group</arm_group_label>
    <other_name>n-butyl-2-cyanoacrylate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.The etiology of portal hypertension is cirrhosis. 2.Age ranges between 20-80 y/o.&#xD;
             3.Patients presenting with history of gastric variceal bleeding or acute gastric&#xD;
             variceal bleeding proven by emergency endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) association with severe systemic illness, such as sepsis, CVA, COPD, advanced&#xD;
             carcinoma, hepatocellular carcinoma (Barcelona Club Liver Cancer class C or D) 2)&#xD;
             presence of massive ascites 3), serum creatinine &gt;3mg/dl, hepatic encephalopathy &gt;&#xD;
             stage II, 4) serum bilirubin &gt; 10mg/dl 5) life expectancy less than 24 hours 6)&#xD;
             Child-Pugh's scores &gt; 13 7) pregnancy 8) has ulcers on gastric varices 9)&#xD;
             Uncooperative&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>E-DA Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>824</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gin-Ho Lo, M.D</last_name>
      <phone>886-7-6150011</phone>
      <phone_ext>1629</phone_ext>
      <email>ghlo@kimo.com</email>
    </contact>
    <investigator>
      <last_name>Gin-Ho Lo, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>November 2, 2012</last_update_submitted>
  <last_update_submitted_qc>November 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>E-DA Hospital</investigator_affiliation>
    <investigator_full_name>Gin-Ho Lo</investigator_full_name>
    <investigator_title>Vice Superintendent, E-DA Hospital</investigator_title>
  </responsible_party>
  <keyword>gastric varices, thrombin, histoacryl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal and Gastric Varices</mesh_term>
    <mesh_term>Varicose Veins</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01717612
org study id: Thrombin study
nct id: NCT01717612
lead sponsor: 
collaborator: 
has dmc: No
Though histoacryl injection is now regarded as treatment of choice in the control of gastric
      variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer
      bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On
      the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding
      gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were
      between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without
      inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.
Previous studies have proven that the use of cyanoacrylate glue injection was superior to EIS
      or EVL in arresting acute gastric variceal bleeding. Endoscopic obturation with glue
      injection has gained worldwide popularity except the United States. The hemostatic rates of
      glue injection ranged from 87% to 100%, with rebleeding rates about 7% to 71%.

      Though histoacryl injection is now regarded as treatment of choice in the control of gastric
      variceal hemorrhage, it may be associated with a lot of complications such as ulcers, ulcer
      bleeding, bacterial infections, distant site thrombosis and cerebral vascular accident. On
      the other hand, thrombin has been shown to be effective in acute hemostasis of bleeding
      gastric varices, ranging from 70% to 100% has been recorded. The rebleeding rates were
      between 7% and 50%. Moreover, the benefits of thrombin injection include safety, without
      inducing ulcers or ulcer bleeding. No incidence of distant thrombosis has ever been reported.
      The mechanism of hemostasis induced by thrombin is through the conversion of fibrinogen to
      fibrin and enhancement of platelets aggregation. This trial aimed to compare the relative
      efficacy and safety between histoacryl injection and thrombin injection in the prevention of
      gastric variceal rebleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ulcer on gastric varices
time frame: 1 month after therapy
description: ulcer crater or ulcer with bleeding from gastric varices
measure: rebleeding
time frame: 6 weeks
description: rebleeding from gastric varices
arm group label: Histoacryl group
arm group type: Active Comparator
description: the injected agents consisted of n-butyl-2-cyanoacrylate (Histoacryl; B.Braun, Melsungen AG, Germany) 0.5ml mixed with 1.5 ml Lipiodol ultra-fluide (Guerbet, Bois Cedex, France). The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.
arm group label: thrombin group
arm group type: Experimental
description: Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)
intervention type: Drug
intervention name: Thrombin
description: Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)
arm group label: thrombin group
intervention type: Drug
intervention name: Histoacryl
description: The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.
arm group label: Histoacryl group
other name: n-butyl-2-cyanoacrylate
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: E-DA Hospital
investigator full name: Gin-Ho Lo
investigator title: Vice Superintendent, E-DA Hospital
mesh term: Esophageal and Gastric Varices
mesh term: Varicose Veins
mesh term: Thrombin