<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/NCT02238288</url>
  </required_header>
  <id_info>
    <org_study_id>AEAC2014</org_study_id>
    <nct_id>NCT02238288</nct_id>
  </id_info>
  <brief_title>Randomized Clinical Trial With Aminocaproic Acid in the Prevention of Exodontic Bleeding in Anticoagulants Patients</brief_title>
  <official_title>Randomized Clinical Trial to Verify the Effectiveness of Topical Aminocaproic Acid in the Prevention of Post-exodontic Bleeding in Patients on Anticoagulants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grupo de Estudos Multicentricos em Onco-Hematologia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rio de Janeiro State Research Supporting Foundation (FAPERJ)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grupo de Estudos Multicentricos em Onco-Hematologia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients using anticoagulants present an increased risk of bleeding when subjected to oral&#xD;
      surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures,&#xD;
      may result in thromboembolic events, putting patients health in risk. Recent studies advocate&#xD;
      the dental surgery treatment without suspending the anticoagulant therapy, since the values&#xD;
      of the international normalized ratio (INR) are in acceptable therapeutic levels and local&#xD;
      measurements are taken for the hemostasis control. The aim of this study is to compare the&#xD;
      effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated to daily&#xD;
      rinses with the drug, with routine post-surgical procedures, to control the post-exodontic&#xD;
      bleeding in anticoagulated patients. Patients will be referred by the anticoagulation clinic&#xD;
      of the Clementino Fraga Filho University Hospital. Once the study criteria is met patients&#xD;
      will be randomly allocated into two groups and subsequently subjected to clinical and&#xD;
      periodontal examination, radiographic examination and pre-operative periodontal therapy.&#xD;
      Laboratory tests (partial thromboplastic time, prothrombin time, international normalized&#xD;
      ratio and platelet count) will be held on the day of the extraction. Patients in group 1 (&#xD;
      EACA ) will receive a paste composed of 01 macerated EACA tablet (500 mg), mixed with 0.9%&#xD;
      saline solution in the alveolar socket, and routine post-operative care. Additionally,&#xD;
      patients will perform oral rinses three times a day, on the first two post-operative days,&#xD;
      with a solution from the macerated EACA 500mg tablet diluted in 2 spoons of filtered water.&#xD;
      Patients allocated in group 2 (control) will receive routine post-operative care.&#xD;
      Classification of immediate bleeding will be held by the professional, on the day of the&#xD;
      surgery, immediately after the suture and twenty minutes later and the delayed bleeding,&#xD;
      recorded by the patient through a daily questionnaire. The Statistical Package for the Social&#xD;
      Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the database and the Chi-square,&#xD;
      Kruskal-Wallis and Mann-Whitney tests will be applied to statistical analysis of the&#xD;
      results.The study was approved by the ethical and research committee of the Clementino Fraga&#xD;
      Filho University Hospital . All patients will sign a free consent and informed term.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients will be submitted to clinical and radiographic examination. Once selected,&#xD;
      patients will receive hygiene instruction and will be submitted to full mouth scaling one&#xD;
      week before the procedure with an ultrasonic device (CavitronR - Dentsply). The random&#xD;
      allocation of patients will obey the order obtained in the computerized program Allocation&#xD;
      1.0 Software© (Isfahan, Iran, 2004). All patients should have the prothrombin time (PT) and&#xD;
      INR, active thromboplastin partial time (aTPT) and platelet counts tests on the day of&#xD;
      surgery. Patients who present INR&lt; 2.0 e &gt; 4 will be assessed by the medical team about the&#xD;
      possibility of change in the dose of medication to the surgical procedure. Patients with&#xD;
      predisposing heart conditions the bacterial endocarditis will receive antibiotic prophylaxis&#xD;
      as recommendations from American Association of Cardiology (AHA) of 2007. All extraction&#xD;
      procedures will be performed by non-traumatic conventional surgical techniques, under local&#xD;
      anesthesia (2% lidocaine and epinephrine 1: 100,000). Just one extraction will be performed&#xD;
      in each surgical procedure, by the same surgeon. All patients will receive digital&#xD;
      compression of socket with sterile gauze for 5 minutes (Chompret 's manoeuver) and suture&#xD;
      with non-resorbable wire, silk 3.0 type . Everyone will receive the base analgesic&#xD;
      prescription Paracetamol 750 mg (Tylenol© - Johnson &amp; Johnson), 01 tablet every 6 hours, by&#xD;
      oral administration, for control of postoperative pain. Patients are divided into two groups:&#xD;
&#xD;
      Group 1 (EACA) - patients will receive the intra-alveolar application of a 500 mg tablet of&#xD;
      the epsilon-amino caproic acid (EACA - Ipsilon® - Nikko Brazil, RJ) crushed in 0.9% saline.&#xD;
      Additionally, they will be instructed to rinse with 500mg EACA tablets macerated and diluted&#xD;
      in 2 tablespoons of water three times a day, in the two days after the extraction.&#xD;
&#xD;
      Group 2 (control) - patients will receive routine postoperative care.&#xD;
&#xD;
      Classification of Bleeding will be performed by the professional on the day of surgery at two&#xD;
      times: one time (immediately after extraction) and time 2 (after 20 minutes). The bleeding&#xD;
      will be classified as follows:&#xD;
&#xD;
        -  No bleeding&#xD;
&#xD;
        -  Light bleeding - blood in saliva&#xD;
&#xD;
        -  Moderate Bleeding - bleeding controlled with local measures&#xD;
&#xD;
        -  Severe Bleeding - when surgical intervention is required&#xD;
&#xD;
      Late bleeding will be recorded by the patient through daily questionnaire. The bleeding will&#xD;
      be classified as follows:&#xD;
&#xD;
        -  No bleeding&#xD;
&#xD;
        -  Blood stained saliva&#xD;
&#xD;
        -  Bleeding that stopped after compression bandage and ice pack for 20 minutes&#xD;
&#xD;
        -  Bleeding stopped only after professional intervention&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2013</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>bleeding post-exodontic</measure>
    <time_frame>up to twenty minutes</time_frame>
    <description>No bleeding&#xD;
Bleeding Light - blood in saliva&#xD;
Moderate Bleeding - bleeding controlled with local measures&#xD;
Severe Bleeding - when required surgical intervention and / or hospitalization</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">154</enrollment>
  <condition>Oral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>aminocaproic acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Crushed tablets inserted in the dental socket post-extraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care after dental extraction</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aminocaproic acid</intervention_name>
    <description>Crushed tablet in the dental socket</description>
    <arm_group_label>aminocaproic acid</arm_group_label>
    <other_name>Ipsilon©</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine dental care</intervention_name>
    <description>Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes</description>
    <arm_group_label>Routine care after dental extraction</arm_group_label>
    <other_name>Routine procedures after dental extractions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine and epinephrine</intervention_name>
    <description>2%</description>
    <arm_group_label>Routine care after dental extraction</arm_group_label>
    <arm_group_label>aminocaproic acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>750 mg</description>
    <arm_group_label>Routine care after dental extraction</arm_group_label>
    <arm_group_label>aminocaproic acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age, use of warfarin sodium with or without anti-platelet&#xD;
             aggregation, indicating simple extractions whose INR values are between 2.0 and 4.0&#xD;
             and that consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with platelet count &lt; 50,000 / mm3 Pregnant women or lactating Patients with&#xD;
             hypersensitivity to the components of EACA. Patients with coagulopathies Patients who&#xD;
             have impacted teeth, ankylosed or root morphological alterations that may complicate&#xD;
             the procedure Patients who fail to submit laboratory and radiographic examinations&#xD;
             necessary for the surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clementino Fraga Filho University Hospital</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>21864-440</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anticoagulation</keyword>
  <keyword>extraction</keyword>
  <keyword>epsilon amino caproic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Aminocaproic Acid</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/NCT02238288
org study id: AEAC2014
nct id: NCT02238288
lead sponsor: 
collaborator: 
has dmc: No
Patients using anticoagulants present an increased risk of bleeding when subjected to oral
      surgery. Suspending or reducing the oral anticoagulant dose to perform invasive procedures,
      may result in thromboembolic events, putting patients health in risk. Recent studies advocate
      the dental surgery treatment without suspending the anticoagulant therapy, since the values
      of the international normalized ratio (INR) are in acceptable therapeutic levels and local
      measurements are taken for the hemostasis control. The aim of this study is to compare the
      effectiveness use of intra-alveolar epsilon amino caproic acid (EACA) associated to daily
      rinses with the drug, with routine post-surgical procedures, to control the post-exodontic
      bleeding in anticoagulated patients. Patients will be referred by the anticoagulation clinic
      of the Clementino Fraga Filho University Hospital. Once the study criteria is met patients
      will be randomly allocated into two groups and subsequently subjected to clinical and
      periodontal examination, radiographic examination and pre-operative periodontal therapy.
      Laboratory tests (partial thromboplastic time, prothrombin time, international normalized
      ratio and platelet count) will be held on the day of the extraction. Patients in group 1 (
      EACA ) will receive a paste composed of 01 macerated EACA tablet (500 mg), mixed with 0.9%
      saline solution in the alveolar socket, and routine post-operative care. Additionally,
      patients will perform oral rinses three times a day, on the first two post-operative days,
      with a solution from the macerated EACA 500mg tablet diluted in 2 spoons of filtered water.
      Patients allocated in group 2 (control) will receive routine post-operative care.
      Classification of immediate bleeding will be held by the professional, on the day of the
      surgery, immediately after the suture and twenty minutes later and the delayed bleeding,
      recorded by the patient through a daily questionnaire. The Statistical Package for the Social
      Sciences (SPSS)© (IBM, Chicago, USA) 20.0 is used as the database and the Chi-square,
      Kruskal-Wallis and Mann-Whitney tests will be applied to statistical analysis of the
      results.The study was approved by the ethical and research committee of the Clementino Fraga
      Filho University Hospital . All patients will sign a free consent and informed term.
All patients will be submitted to clinical and radiographic examination. Once selected,
      patients will receive hygiene instruction and will be submitted to full mouth scaling one
      week before the procedure with an ultrasonic device (CavitronR - Dentsply). The random
      allocation of patients will obey the order obtained in the computerized program Allocation
      1.0 Software© (Isfahan, Iran, 2004). All patients should have the prothrombin time (PT) and
      INR, active thromboplastin partial time (aTPT) and platelet counts tests on the day of
      surgery. Patients who present INR< 2.0 e > 4 will be assessed by the medical team about the
      possibility of change in the dose of medication to the surgical procedure. Patients with
      predisposing heart conditions the bacterial endocarditis will receive antibiotic prophylaxis
      as recommendations from American Association of Cardiology (AHA) of 2007. All extraction
      procedures will be performed by non-traumatic conventional surgical techniques, under local
      anesthesia (2% lidocaine and epinephrine 1: 100,000). Just one extraction will be performed
      in each surgical procedure, by the same surgeon. All patients will receive digital
      compression of socket with sterile gauze for 5 minutes (Chompret 's manoeuver) and suture
      with non-resorbable wire, silk 3.0 type . Everyone will receive the base analgesic
      prescription Paracetamol 750 mg (Tylenol© - Johnson & Johnson), 01 tablet every 6 hours, by
      oral administration, for control of postoperative pain. Patients are divided into two groups:

      Group 1 (EACA) - patients will receive the intra-alveolar application of a 500 mg tablet of
      the epsilon-amino caproic acid (EACA - Ipsilon® - Nikko Brazil, RJ) crushed in 0.9% saline.
      Additionally, they will be instructed to rinse with 500mg EACA tablets macerated and diluted
      in 2 tablespoons of water three times a day, in the two days after the extraction.

      Group 2 (control) - patients will receive routine postoperative care.

      Classification of Bleeding will be performed by the professional on the day of surgery at two
      times: one time (immediately after extraction) and time 2 (after 20 minutes). The bleeding
      will be classified as follows:

        -  No bleeding

        -  Light bleeding - blood in saliva

        -  Moderate Bleeding - bleeding controlled with local measures

        -  Severe Bleeding - when surgical intervention is required

      Late bleeding will be recorded by the patient through daily questionnaire. The bleeding will
      be classified as follows:

        -  No bleeding

        -  Blood stained saliva

        -  Bleeding that stopped after compression bandage and ice pack for 20 minutes

        -  Bleeding stopped only after professional intervention
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: bleeding post-exodontic
time frame: up to twenty minutes
description: No bleeding
Bleeding Light - blood in saliva
Moderate Bleeding - bleeding controlled with local measures
Severe Bleeding - when required surgical intervention and / or hospitalization
arm group label: aminocaproic acid
arm group type: Active Comparator
description: Crushed tablets inserted in the dental socket post-extraction
arm group label: Routine care after dental extraction
arm group type: Other
description: Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
intervention type: Drug
intervention name: Aminocaproic acid
description: Crushed tablet in the dental socket
arm group label: aminocaproic acid
other name: Ipsilon©
intervention type: Other
intervention name: Routine dental care
description: Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
arm group label: Routine care after dental extraction
other name: Routine procedures after dental extractions
intervention type: Drug
intervention name: lidocaine and epinephrine
description: 2%
arm group label: Routine care after dental extraction
arm group label: aminocaproic acid
intervention type: Drug
intervention name: Paracetamol
description: 750 mg
arm group label: Routine care after dental extraction
arm group label: aminocaproic acid
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Oral Hemorrhage
mesh term: Hemorrhage
mesh term: Acetaminophen
mesh term: Lidocaine
mesh term: Epinephrine
mesh term: Aminocaproic Acid