<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/NCT02228798</url>
  </required_header>
  <id_info>
    <org_study_id>CIHR-PAUSE-2014</org_study_id>
    <secondary_id>CIHR313156 HSFG-14-0006163</secondary_id>
    <nct_id>NCT02228798</nct_id>
  </id_info>
  <brief_title>Perioperative Anticoagulant Use for Surgery Evaluation Study</brief_title>
  <acronym>PAUSE</acronym>
  <official_title>Perioperative Anticoagulant Use (Dabigatran, Rivaroxaban, or Apixaban) for Elective Surgery/Procedure Evaluation in Patients With Atrial Fibrillation (AF).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to&#xD;
      establish a safe, standardized protocol for the perioperative management of patients with&#xD;
      atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either&#xD;
      dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim is to demonstrate that a standardized but patient-focused protocol for the&#xD;
      perioperative management of each DOAC is safe, with acceptably low rates of perioperative&#xD;
      major bleeding (MB) and arterial thromboembolism (ATE). The perioperative protocol is&#xD;
      adjusted based on patient renal function and surgery/procedure-related bleed risk, to&#xD;
      optimize patient safety, and does not involve heparin bridging anticoagulation.&#xD;
&#xD;
      The secondary aim of the PAUSE Study is to determine the effect of the pre-operative DOAC&#xD;
      interruption protocol on the level of residual anticoagulation, when measured by 'everyday'&#xD;
      coagulation tests that are not DOAC-specific (e.g., activated partial thromboplastin time&#xD;
      [aPTT]) and 'specialized' coagulation tests that are DOAC-specific (dilute thrombin time [TT]&#xD;
      - HemoclotTM, and anti-factor Xa assays).&#xD;
&#xD;
      Approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited&#xD;
      across Canada for the PAUSE Study.&#xD;
&#xD;
      Patients with Atrial Fibrillation and are currently taking dabigatran, rivaroxaban and&#xD;
      apixaban (DOACs) and require elective surgery/procedure will follow a standardized management&#xD;
      perioperative protocol for discontinuation of their DOAC prior to surgery. Patients will be&#xD;
      discontinuing the DOAC they are currently receiving from 1 to 4 days prior to surgery or&#xD;
      procedure, depending on bleed risk, type of DOAC, and creatinine clearance rate.&#xD;
&#xD;
      A blood sample will be taken on the day of the surgery or procedure for measurement of&#xD;
      laboratory outcomes (residual level of anticoagulant on day of surgery).&#xD;
&#xD;
      Patients will be followed up weekly up to a month for primary outcome assessments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</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>Number of Participants with Major Bleeds</measure>
    <time_frame>Within 30 days of surgery or procedure</time_frame>
    <description>The first primary outcome is Major Bleed:Bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular.&#xD;
Non-surgical bleeding causing a drop in hemoglobin greater than or equal to 20 g per L or leading to transfusion greater or equal to 2 units of blood within 24 hours.Surgical bleed that leads to intervention or interferes with mobilization or leads to delayed wound healing; or leads to deep wound infection.&#xD;
Surgical site bleeding that is unexpected and prolonged and or sufficiently large to cause hemodynamic instability associated with a drop in hemoglobin greater or equal to 20 g per L or transfusion of greater or equal to 2 units of blood within 24 hours.&#xD;
The second primary outcome is atrial thromboembolism (ATE), comprising: Ischemic stroke,Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ or transient ischemic attack.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with Atrial Thromboembolism</measure>
    <time_frame>Within 30 days of surgery or procedure</time_frame>
    <description>The second primary outcome is atrial thromboembolism (ATE), comprising:&#xD;
Ischemic stroke: any new focal neurologic deficit that persists for &gt;24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain.&#xD;
Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging studies (e.g. CT angiography).&#xD;
Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically less than 1 hour), that occurs with no evidence of acute infarction on CT or MRI of brain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Minor bleeding</measure>
    <time_frame>30 days or less after surgery or porcedure</time_frame>
    <description>• Minor bleeding: bleeding not satisfying criteria for major bleeding; investigator will report bleeding events using pertinent clinical data and with an assessment from the surgeon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who die</measure>
    <time_frame>30 days or after surgery or procedure</time_frame>
    <description>Death: death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants that have a Venous Thromboembolism (VTE)</measure>
    <time_frame>30 days or less after surgery</time_frame>
    <description>Venous thromboembolism (VTE): comprising symptomatic deep vein thrombosis and pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who acquire Acute Coronary Syndrome</measure>
    <time_frame>30 days or less after surgery or procedure</time_frame>
    <description>• Acute coronary syndrome: symptomatic myocardial ischemia, defined by pre-specified clinical and objective EKG- and/or troponin-related criteria N.B. Patients who develop any clinical outcome will be treated according to standards of care.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dilute TT test-Laboratory blood test of NOAC levels</measure>
    <time_frame>Day of Surgery</time_frame>
    <description>• DOAC levels will be measured by the dilute TT test expressed in ng/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anti-Xa test for NOAC level</measure>
    <time_frame>Day of surgery</time_frame>
    <description>DOAC levels as measured by an anti-Xa tests, expressed in ng/mL.</description>
  </other_outcome>
  <other_outcome>
    <measure>INR Laboratory Test</measure>
    <time_frame>Day of surgery</time_frame>
    <description>• The INR will be done to compare these tests with novel oral anticoagulant specialized Anti-Xa tests</description>
  </other_outcome>
  <other_outcome>
    <measure>PT Laboratory test</measure>
    <time_frame>Day of surgery</time_frame>
    <description>PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests</description>
  </other_outcome>
  <other_outcome>
    <measure>aPTT Laboratory test</measure>
    <time_frame>Day of Surgery</time_frame>
    <description>To compare these tests with novel oral anticoagulant specialized Anti-Xa tests</description>
  </other_outcome>
  <other_outcome>
    <measure>TT Laboratory test</measure>
    <time_frame>Day of surgery</time_frame>
    <description>To compare these tests with novel oral anticoagulant specialized Anti-Xa tests</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">3135</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Rivaroxaban</arm_group_label>
    <description>Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dabigatran</arm_group_label>
    <description>Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Apixaban</arm_group_label>
    <description>Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood (platelet deprived plasma) will be collected on day of surgery/procedure and measured&#xD;
      by 'everyday' coagulation tests that are not DOAC-specific (e.g., activated partial&#xD;
      thromboplastin time [aPTT]) and 'specialized' coagulation tests that are DOAC-specific&#xD;
      (dilute thrombin time [TT] - HemoclotTM, and anti-factor Xa assays) to determine the effect&#xD;
      of the pre-operative DOAC interruption protocol on the level of residual anticoagulation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Those patients who are currently taking dabigatran, rivaroxaban or apixaban for oral&#xD;
        anticoagulation used for stroke prevention in atrial fibrillation, and who require its&#xD;
        temporary interruption for a surgical or other procedure, will be recruited from 15 to 25&#xD;
        participating sites across Canada.&#xD;
&#xD;
        The study plans to screen 4,114 patients over a 3 year period, with 80 per cent expected&#xD;
        enrollment (3,291 patients) from 16 sites across Canada. Equal number of patients, per oral&#xD;
        anticoagulant arm will be enrolled, with approximately 1,000 patients taking each DOAC.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older&#xD;
&#xD;
          2. Receiving a DOAC (dabigatran or rivaroxaban or apixaban) for Atrial Fibrillation&#xD;
&#xD;
          3. Ability to assess patient at lease one day prior to DOAC discontinuation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. CrCl less than 30 mL per min for dabigatran- and rivaroxaban-treated patients ( less&#xD;
             than 25 mL per min for apixaban-treated patients) as estimated by Cockroft-Gault&#xD;
             formula&#xD;
&#xD;
          2. Cognitive impairment or psychiatric illness that precludes collection of followup data&#xD;
&#xD;
          3. Inability or unwillingness to provide 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>James Douketis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University/St. Joseph's Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pharmacy, Kaiser Permanente Colorado, Aurora, CO, USA</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiovascular Sciences, University of Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Hospital</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North York General</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maisonneuve-Rosemont</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Anesthesiology, University of Thessaly</name>
      <address>
        <city>Larissa</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Vascular Medicine, Amsterdam Cardiovascular Sciences</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Greece</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>June 26, 2019</last_update_submitted>
  <last_update_submitted_qc>June 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMaster University</investigator_affiliation>
    <investigator_full_name>James Douketis</investigator_full_name>
    <investigator_title>Dr. James Douketis-Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>anticoagulant</keyword>
  <keyword>atrial fibrillation</keyword>
  <keyword>surgery</keyword>
  <keyword>oral anticoagulant</keyword>
  <keyword>discontinue</keyword>
  <keyword>DOAC</keyword>
  <keyword>NOAC</keyword>
  <keyword>blood thinner</keyword>
  <keyword>interruption</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_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/NCT02228798
org study id: CIHR-PAUSE-2014
secondary id: CIHR313156 HSFG-14-0006163
nct id: NCT02228798
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The aim of the Perioperative Anticoagulant Use for Surgery Evaluation (PAUSE) Study, is to
      establish a safe, standardized protocol for the perioperative management of patients with
      atrial fibrillation (AF) who are receiving a novel oral anticoagulant (DOAC) drug, either
      dabigatran, rivaroxaban or apixaban, and require an elective surgery/procedure.
The primary aim is to demonstrate that a standardized but patient-focused protocol for the
      perioperative management of each DOAC is safe, with acceptably low rates of perioperative
      major bleeding (MB) and arterial thromboembolism (ATE). The perioperative protocol is
      adjusted based on patient renal function and surgery/procedure-related bleed risk, to
      optimize patient safety, and does not involve heparin bridging anticoagulation.

      The secondary aim of the PAUSE Study is to determine the effect of the pre-operative DOAC
      interruption protocol on the level of residual anticoagulation, when measured by 'everyday'
      coagulation tests that are not DOAC-specific (e.g., activated partial thromboplastin time
      [aPTT]) and 'specialized' coagulation tests that are DOAC-specific (dilute thrombin time [TT]
      - HemoclotTM, and anti-factor Xa assays).

      Approximately 3,300 patients from 15 to 25 centres over a 3.5 year period will be recruited
      across Canada for the PAUSE Study.

      Patients with Atrial Fibrillation and are currently taking dabigatran, rivaroxaban and
      apixaban (DOACs) and require elective surgery/procedure will follow a standardized management
      perioperative protocol for discontinuation of their DOAC prior to surgery. Patients will be
      discontinuing the DOAC they are currently receiving from 1 to 4 days prior to surgery or
      procedure, depending on bleed risk, type of DOAC, and creatinine clearance rate.

      A blood sample will be taken on the day of the surgery or procedure for measurement of
      laboratory outcomes (residual level of anticoagulant on day of surgery).

      Patients will be followed up weekly up to a month for primary outcome assessments.
observational model: Cohort
time perspective: Prospective
measure: Number of Participants with Major Bleeds
time frame: Within 30 days of surgery or procedure
description: The first primary outcome is Major Bleed:Bleeding that is fatal or is symptomatic and retroperitoneal, intracranial, intraspinal, intraocular, pericardial, intramuscular with compartment syndrome, or intra-articular.
Non-surgical bleeding causing a drop in hemoglobin greater than or equal to 20 g per L or leading to transfusion greater or equal to 2 units of blood within 24 hours.Surgical bleed that leads to intervention or interferes with mobilization or leads to delayed wound healing; or leads to deep wound infection.
Surgical site bleeding that is unexpected and prolonged and or sufficiently large to cause hemodynamic instability associated with a drop in hemoglobin greater or equal to 20 g per L or transfusion of greater or equal to 2 units of blood within 24 hours.
The second primary outcome is atrial thromboembolism (ATE), comprising: Ischemic stroke,Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ or transient ischemic attack.
measure: Number of participants with Atrial Thromboembolism
time frame: Within 30 days of surgery or procedure
description: The second primary outcome is atrial thromboembolism (ATE), comprising:
Ischemic stroke: any new focal neurologic deficit that persists for >24 hours or any new focal neurologic deficit of any duration, that occurs with evidence of acute infarction on computed tomography (CT) or magnetic resonance imaging (MRI) of the brain.
Systemic embolism: symptomatic embolism to upper or lower extremity or abdominal organ, confirmed intra-operatively or by objective imaging studies (e.g. CT angiography).
Transient ischemic attack: symptomatic focal neurologic deficit (lasting typically less than 1 hour), that occurs with no evidence of acute infarction on CT or MRI of brain.
measure: Number of participants with Minor bleeding
time frame: 30 days or less after surgery or porcedure
description: • Minor bleeding: bleeding not satisfying criteria for major bleeding; investigator will report bleeding events using pertinent clinical data and with an assessment from the surgeon.
measure: Number of participants who die
time frame: 30 days or after surgery or procedure
description: Death: death due to any cause.
measure: Number of participants that have a Venous Thromboembolism (VTE)
time frame: 30 days or less after surgery
description: Venous thromboembolism (VTE): comprising symptomatic deep vein thrombosis and pulmonary embolism, confirmed by objective imaging studies (e.g., ultrasound, CT pulmonary angiogram).
measure: Number of participants who acquire Acute Coronary Syndrome
time frame: 30 days or less after surgery or procedure
description: • Acute coronary syndrome: symptomatic myocardial ischemia, defined by pre-specified clinical and objective EKG- and/or troponin-related criteria N.B. Patients who develop any clinical outcome will be treated according to standards of care.
measure: Dilute TT test-Laboratory blood test of NOAC levels
time frame: Day of Surgery
description: • DOAC levels will be measured by the dilute TT test expressed in ng/mL.
measure: Anti-Xa test for NOAC level
time frame: Day of surgery
description: DOAC levels as measured by an anti-Xa tests, expressed in ng/mL.
measure: INR Laboratory Test
time frame: Day of surgery
description: • The INR will be done to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
measure: PT Laboratory test
time frame: Day of surgery
description: PT will be measured to compare these tests with novel oral anticoagulant specialized Anti-Xa tests
measure: aPTT Laboratory test
time frame: Day of Surgery
description: To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
measure: TT Laboratory test
time frame: Day of surgery
description: To compare these tests with novel oral anticoagulant specialized Anti-Xa tests
arm group label: Rivaroxaban
description: Patients currently taking rivaroxaban that have atrial fibrillation and require surgery or a procedure.
arm group label: Dabigatran
description: Patients currently taking dabigatran that have atrial fibrillation and require surgery or a procedure.
arm group label: Apixaban
description: Patients currently taking apixaban that have atrial fibrillation and require surgery or a procedure.
Blood (platelet deprived plasma) will be collected on day of surgery/procedure and measured
      by 'everyday' coagulation tests that are not DOAC-specific (e.g., activated partial
      thromboplastin time [aPTT]) and 'specialized' coagulation tests that are DOAC-specific
      (dilute thrombin time [TT] - HemoclotTM, and anti-factor Xa assays) to determine the effect
      of the pre-operative DOAC interruption protocol on the level of residual anticoagulation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James Douketis, MD
role: Principal Investigator
affiliation: McMaster University/St. Joseph's Healthcare
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Canada
country: Greece
country: Netherlands
country: United States
responsible party type: Principal Investigator
investigator affiliation: McMaster University
investigator full name: James Douketis
investigator title: Dr. James Douketis-Principal Investigator
mesh term: Atrial Fibrillation