<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/NCT02982733</url>
  </required_header>
  <id_info>
    <org_study_id>ATADEK2016/17-4</org_study_id>
    <nct_id>NCT02982733</nct_id>
  </id_info>
  <brief_title>Ankaferd Blood Stopper for Hemostasis After Transradial Coronary Angiography</brief_title>
  <official_title>Ankaferd Blood Stopper as a New Strategy to Avoid Early Complication After Transradial Coronary Angiography: A Randomized, Placebo-Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acibadem University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Acibadem University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug.&#xD;
      Recently, ABS has been shown to produce local hemostasis by implementing topically after&#xD;
      major arterial vessel injury. Reducing the compression time during patent hemostasis by&#xD;
      facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a&#xD;
      three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in&#xD;
      adjunct to short-time compression, compared to either short-time compression with&#xD;
      conventional sterile gauzes or with a TR band after transradial diagnostic procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radial artery occlusion assessed by reverse Barbeau's test</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>2 hours</time_frame>
    <description>any kind of bleeding defined as ml after the removal of hemostatic dressings or devices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma</measure>
    <time_frame>24 hours</time_frame>
    <description>hematomas larger then &gt;5cm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Radial Artery Injury</condition>
  <condition>Hematoma</condition>
  <condition>Bleed</condition>
  <arm_group>
    <arm_group_label>ABS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ankaferd blood stopper</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional sterile gauze</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TR BAND</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dedicated hemostatic device</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ABS</intervention_name>
    <description>Ankaferd Blood Stopper</description>
    <arm_group_label>ABS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TR Band</intervention_name>
    <description>Transradial band</description>
    <arm_group_label>TR BAND</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CS</intervention_name>
    <description>Sterile Gauze</description>
    <arm_group_label>CS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive patients undergoing transradial elective diagnostic coronary&#xD;
             procedures between November 2016 and November 2017 at the catheterization laboratory&#xD;
             of Acibadem University Kocaeli Hospital were considered to be enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The only exclusion criteria were an abnormal Barbeau's test before puncture and&#xD;
             failure to provide written informed consent.&#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>Sevket Gorgulu, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Acibadem University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sevket Gorgulu, Prof</last_name>
    <phone>02623174121</phone>
    <email>sevket5@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Acibadem University</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sevket Gorgulu, MD</last_name>
      <email>sevket5@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Sevket Gorgulu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Acibadem University</investigator_affiliation>
    <investigator_full_name>Sevket Gorgulu</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematoma</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>October 26, 2017</submitted>
    <returned>July 31, 2018</returned>
    <submitted>August 27, 2018</submitted>
    <returned>January 30, 2019</returned>
  </pending_results>
  <!-- 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/NCT02982733
org study id: ATADEK2016/17-4
nct id: NCT02982733
lead sponsor: 
has dmc: No
In 2008 Goker et al, introduced Ankaferd Blood Stopper (ABS) as a new hemostatic drug.
      Recently, ABS has been shown to produce local hemostasis by implementing topically after
      major arterial vessel injury. Reducing the compression time during patent hemostasis by
      facilitating hemostasis may decrease RAO. To test this hypothesis the investigators planned a
      three arm randomized study to evaluate the safety and efficacy of Ankaferd blood stopper in
      adjunct to short-time compression, compared to either short-time compression with
      conventional sterile gauzes or with a TR band after transradial diagnostic procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Radial artery occlusion assessed by reverse Barbeau's test
time frame: 24 hours
measure: Bleeding
time frame: 2 hours
description: any kind of bleeding defined as ml after the removal of hemostatic dressings or devices
measure: Hematoma
time frame: 24 hours
description: hematomas larger then >5cm
arm group label: ABS
arm group type: Active Comparator
description: Ankaferd blood stopper
arm group label: CS
arm group type: Placebo Comparator
description: Conventional sterile gauze
arm group label: TR BAND
arm group type: Active Comparator
description: Dedicated hemostatic device
intervention type: Other
intervention name: ABS
description: Ankaferd Blood Stopper
arm group label: ABS
intervention type: Device
intervention name: TR Band
description: Transradial band
arm group label: TR BAND
intervention type: Other
intervention name: CS
description: Sterile Gauze
arm group label: CS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sevket Gorgulu, Prof
role: Study Chair
affiliation: Acibadem University
last name: Sevket Gorgulu, Prof
phone: 02623174121
email: sevket5@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Acibadem University
investigator full name: Sevket Gorgulu
investigator title: Prof. Dr.
mesh term: Hematoma
submitted: October 26, 2017
returned: July 31, 2018
submitted: August 27, 2018
returned: January 30, 2019