<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/NCT02255214</url>
  </required_header>
  <id_info>
    <org_study_id>2013/0300</org_study_id>
    <nct_id>NCT02255214</nct_id>
  </id_info>
  <brief_title>Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Device Compared With Laboratory Assay</brief_title>
  <official_title>Evaluation of the Accuracy of the Hemochron Signature Elite Point of Care Micro Coagulation Instrument Compared With Laboratory Assay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NHS Lothian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NHS Lothian</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages&#xD;
      over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest&#xD;
      a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or&#xD;
      greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its&#xD;
      effects is required.&#xD;
&#xD;
      The Hemochron Signature Elite is a portable micro coagulation system that can be used as a&#xD;
      point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy,&#xD;
      convenience and efficiency in delivering a coagulation result.&#xD;
&#xD;
      This study will assess the accuracy of this device in calculating the International&#xD;
      Normalised Ratio (INR) result. This will be compared to another INR result obtained on the&#xD;
      same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh&#xD;
      (RIE) laboratories.&#xD;
&#xD;
      The study will include patients presenting for surgery who have had their warfarin therapy&#xD;
      stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are&#xD;
      currently identified in preoperative assessment clinics, on average 12 weeks prior to their&#xD;
      date of surgery.&#xD;
&#xD;
      Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC&#xD;
      device is used. Concern exists that patients may be inappropriately denied the potential&#xD;
      benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or&#xD;
      conversely the investigators may be proceeding with CNB in patients with an unacceptably high&#xD;
      INR if POC provides a falsely low result. There is also the possibility of improving hospital&#xD;
      efficiency using this device as it provides a result much faster than the laboratory.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2013</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Blood Coagulation Tests</condition>
  <arm_group>
    <arm_group_label>Surgical Patient</arm_group_label>
    <description>These are the results from the blood samples taken from the study participants.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all adult patients presenting for elective surgery who&#xD;
        have stopped their warfarin therapy within the last 7 days. They will be approached in the&#xD;
        Day Surgery Unit and Day of Surgery Assessment unit within a single centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients presenting for elective surgery who have stopped their warfarin therapy&#xD;
             within the last 7 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults with incapacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cameron R Ferguson, MBChB MRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lothian</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Cameron R Ferguson, MBChB MRCP</last_name>
    <email>cameronferguson@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gary Morrison, MBChB FRCA</last_name>
    <email>gary.morrison@nhslothian.scot.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Infirmary Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <state>Lothian</state>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Maitland</last_name>
      <email>karen.maitland@nhslothian.scot.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>February 14, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>September 29, 2014</last_update_submitted>
  <last_update_submitted_qc>September 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NHS Lothian</investigator_affiliation>
    <investigator_full_name>Cameron Ferguson</investigator_full_name>
    <investigator_title>Dr Cameron Ferguson</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>October 5, 2015</submitted>
    <returned>November 5, 2015</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/NCT02255214
org study id: 2013/0300
nct id: NCT02255214
lead sponsor: 
has dmc: No
Central Neuraxial Blockade (CNB) is commonly used in anaesthetics. It has several advantages
      over a general anaesthetic however contraindications include coagulopathy. Guidelines suggest
      a CNB should not be undertaken with an International Normalised Ratio (INR) of 1.5 or
      greater. A common cause of an elevated INR is warfarin therapy and regular monitoring of its
      effects is required.

      The Hemochron Signature Elite is a portable micro coagulation system that can be used as a
      point of care (POC) anticoagulation monitoring device. Marketing is focussed on its accuracy,
      convenience and efficiency in delivering a coagulation result.

      This study will assess the accuracy of this device in calculating the International
      Normalised Ratio (INR) result. This will be compared to another INR result obtained on the
      same sample via the current gold standard testing equipment in the Royal Infirmary Edinburgh
      (RIE) laboratories.

      The study will include patients presenting for surgery who have had their warfarin therapy
      stopped within the previous 7 days. Patients on warfarin therapy requiring surgery are
      currently identified in preoperative assessment clinics, on average 12 weeks prior to their
      date of surgery.

      Anecdotally there appears to be a difference between the 'expected' and actual INR when a POC
      device is used. Concern exists that patients may be inappropriately denied the potential
      benefits of central neural blockade (CNB) if a POC device provides a falsely high result, or
      conversely the investigators may be proceeding with CNB in patients with an unacceptably high
      INR if POC provides a falsely low result. There is also the possibility of improving hospital
      efficiency using this device as it provides a result much faster than the laboratory.
observational model: Cohort
time perspective: Prospective
measure: The International Normalised Ratio (INR) will be measured by the laboratory assay and the Hemochron Signature Elite device.
time frame: 18 months
arm group label: Surgical Patient
description: These are the results from the blood samples taken from the study participants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Cameron R Ferguson, MBChB MRCP
role: Principal Investigator
affiliation: NHS Lothian
last name: Cameron R Ferguson, MBChB MRCP
email: cameronferguson@nhs.net
last name: Gary Morrison, MBChB FRCA
email: gary.morrison@nhslothian.scot.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: NHS Lothian
investigator full name: Cameron Ferguson
investigator title: Dr Cameron Ferguson
submitted: October 5, 2015
returned: November 5, 2015