<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/NCT04505475</url>
  </required_header>
  <id_info>
    <org_study_id>01-11/45-2015 DCV</org_study_id>
    <nct_id>NCT04505475</nct_id>
  </id_info>
  <brief_title>Oral Surgery in Patients Taking Direct Oral Anticoagulants</brief_title>
  <acronym>OSDOA</acronym>
  <official_title>Oral Surgery in Patients Taking Direct Oral Anticoagulants and Vitamin K Antagonists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Novi Sad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Novi Sad</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>
      This study evaluates the incidence of postoperative bleeding after oral surgical procedures&#xD;
      in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of&#xD;
      thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for&#xD;
      clinical use, mostly in prevention of stroke and systemic embolisms in patients with&#xD;
      nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous&#xD;
      studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic&#xD;
      (International Normalized Ratio) INR levels can be safely performed without therapy&#xD;
      interruption if proper local haemostatic measures are applied. Similar recommendations were&#xD;
      given for the dental treatment of patients taking DOACs, but there is a lack of clinical&#xD;
      studies. The aim of this study is to assess the incidence of bleeding complications after&#xD;
      oral surgery in patients who continue their DOACs or VKA medications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2015</start_date>
  <completion_date type="Actual">August 3, 2020</completion_date>
  <primary_completion_date type="Actual">August 3, 2020</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>Postoperative bleeding event</measure>
    <time_frame>7 days</time_frame>
    <description>Bleeding that requires additional surgical procedure</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">82</enrollment>
  <condition>Anticoagulants and Bleeding Disorders</condition>
  <condition>Surgery</condition>
  <condition>Postoperative Hemorrhage</condition>
  <condition>Dentoalveolar Haemorrhage</condition>
  <arm_group>
    <arm_group_label>Direct oral anticoagulants</arm_group_label>
    <description>Patients taking dabigatran, ravaroxaban or apixaban</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vitamin K antagonists</arm_group_label>
    <description>Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)</intervention_name>
    <description>single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy</description>
    <arm_group_label>Direct oral anticoagulants</arm_group_label>
    <arm_group_label>Vitamin K antagonists</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study includes patients taking direct oral anticoagulants (DOACs) and patients taking&#xD;
        vitamin K antagonists (VKA) who require oral surgical procedure. The groups will be matched&#xD;
        with respect to oral surgical procedure i.e. operative trauma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients over 18 years&#xD;
&#xD;
          -  Patients taking regularly direct anticoagulant therapy: dabigatran, rivaroxaban or&#xD;
             apixaban (DOACs group)&#xD;
&#xD;
          -  Patients taking regularly acenocoumarol with INR 2.0-3.5 on the day of the surgery&#xD;
             (VKA group)&#xD;
&#xD;
          -  Indication for oral surgical procedure&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver or renal disease&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Allergy to lidocaine&#xD;
&#xD;
          -  Patients who stopped taking their anticoagulant medication&#xD;
&#xD;
          -  Patients taking VKA with INR &lt;2.0 or &gt;3.5 on the day of the procedure&#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>Branislav Bajkin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Novi Sad, Faculty of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dental Clinic of Vojvodina</name>
      <address>
        <city>Novi Sad</city>
        <state>Vojvodina</state>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 10, 2020</last_update_submitted>
  <last_update_submitted_qc>August 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Novi Sad</investigator_affiliation>
    <investigator_full_name>Branislav Bajkin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>oral anticoagulants</keyword>
  <keyword>dabigatran</keyword>
  <keyword>rivaroxaban</keyword>
  <keyword>warfarin</keyword>
  <keyword>oral surgery</keyword>
  <keyword>hemorrhage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Postoperative Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemostatics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04505475
org study id: 01-11/45-2015 DCV
nct id: NCT04505475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the incidence of postoperative bleeding after oral surgical procedures
      in patients taking direct oral anticoagulants and in patients taking vitamin K antagonists.
Vitamin K antagonists (VKA) are widely used in long term prevention and treatment of
      thromboembolism. In the last few years direct oral anticoagulants (DOACs) are available for
      clinical use, mostly in prevention of stroke and systemic embolisms in patients with
      nonvalvular atrial fibrillation, and prevention and treatment of venous thrombosis. Numerous
      studies confirmed that minor oral surgical procedures in patients taking VKA with therapeutic
      (International Normalized Ratio) INR levels can be safely performed without therapy
      interruption if proper local haemostatic measures are applied. Similar recommendations were
      given for the dental treatment of patients taking DOACs, but there is a lack of clinical
      studies. The aim of this study is to assess the incidence of bleeding complications after
      oral surgery in patients who continue their DOACs or VKA medications.
observational model: Cohort
time perspective: Prospective
measure: Postoperative bleeding event
time frame: 7 days
description: Bleeding that requires additional surgical procedure
arm group label: Direct oral anticoagulants
description: Patients taking dabigatran, ravaroxaban or apixaban
arm group label: Vitamin K antagonists
description: Patients taking acenocoumarol with therapeutic INR levels (2.0-3.5)
intervention type: Procedure
intervention name: Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)
description: single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy
arm group label: Direct oral anticoagulants
arm group label: Vitamin K antagonists
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Branislav Bajkin, PhD
role: Principal Investigator
affiliation: University of Novi Sad, Faculty of Medicine
facility: 
country: Serbia
responsible party type: Principal Investigator
investigator affiliation: University of Novi Sad
investigator full name: Branislav Bajkin
investigator title: Principal Investigator
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
mesh term: Hemorrhage
mesh term: Postoperative Hemorrhage
mesh term: Hemostatics
sharing ipd: No