<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/NCT02240732</url>
  </required_header>
  <id_info>
    <org_study_id>STCE2.0</org_study_id>
    <nct_id>NCT02240732</nct_id>
  </id_info>
  <brief_title>Surgical Tourniquets and Cerebral Emboli</brief_title>
  <official_title>Surgical Tourniquets and Cerebral Emboli Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Coventry and Warwickshire NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Coventry and Warwickshire NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England,&#xD;
      Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a&#xD;
      surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's&#xD;
      leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can&#xD;
      therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative&#xD;
      tourniquet can therefore help to improve the surgical field of view. Although the majority of&#xD;
      surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are&#xD;
      now not pursuing these devices.&#xD;
&#xD;
      There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet&#xD;
      is used for TKR surgery. In addition embolic material in the venous system have been observed&#xD;
      following TKR surgery and have been noted to be present in the right atrium with&#xD;
      transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening&#xD;
      emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous&#xD;
      shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical&#xD;
      manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood.&#xD;
      Fat embolism syndrome and post-operative confusion in TKR patients may be the result of&#xD;
      emboli formed during a TKR. ,&#xD;
&#xD;
      AIM&#xD;
&#xD;
        -  Is there evidence of emboli entering the cerebral circulation following tourniquet&#xD;
           deflation in TKR surgery?&#xD;
&#xD;
        -  Is there evidence of MRI detectable brain lesions and or any clinical change in&#xD;
           cognition compared in patients undergoing TKR surgery with a tourniquet compared to&#xD;
           those that do not have a tourniquet?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 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>Number of Emboli on Transcranial Doppler</measure>
    <time_frame>Intra-operative</time_frame>
    <description>2 independent technicians will verify the number of emboli detected. Non-invasive</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI brain scan - presence of Emboli</measure>
    <time_frame>Post-operatively, prior to discharge</time_frame>
    <description>Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mini-mental state examination</measure>
    <time_frame>Pre-operative vs Post-operative</time_frame>
    <description>Set of 30 questions which test cognitive function</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Osteoarthritis</condition>
  <condition>RA</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Total knee replacement patients</arm_group_label>
    <description>Patients who are due to have a total knee replacement will be studied to look for the presence of Emboli.&#xD;
Observational with imaging.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are due to have a total knee replacement.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  i.Aged &gt;18&#xD;
&#xD;
          -  ii.Undergoing elective TKR&#xD;
&#xD;
          -  iii.Able to give written informed consent&#xD;
&#xD;
          -  iv.No contraindications to MR imaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  i. Ages &lt;16&#xD;
&#xD;
          -  ii. Not able to give written informed consent&#xD;
&#xD;
          -  iv. Contraindications to MR imaging&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Victoria Gibbs, BA, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>UHCW</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Warwickshire and Coventry</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.</citation>
    <PMID>21161177</PMID>
  </reference>
  <reference>
    <citation>Parmet JL, Horrow JC, Pharo G, Collins L, Berman AT, Rosenberg H. The incidence of venous emboli during extramedullary guided total knee arthroplasty. Anesth Analg. 1995 Oct;81(4):757-62. doi: 10.1097/00000539-199510000-00017.</citation>
    <PMID>7574006</PMID>
  </reference>
  <reference>
    <citation>Parmet JL, Berman AT, Horrow JC, Harding S, Rosenberg H. Thromboembolism coincident with tourniquet deflation during total knee arthroplasty. Lancet. 1993 Apr 24;341(8852):1057-8. doi: 10.1016/0140-6736(93)92414-o.</citation>
    <PMID>8096961</PMID>
  </reference>
  <reference>
    <citation>Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52. doi: 10.1016/0883-5403(94)90057-4.</citation>
    <PMID>7964778</PMID>
  </reference>
  <reference>
    <citation>Pugsley W, Klinger L, Paschalis C, Treasure T, Harrison M, Newman S. The impact of microemboli during cardiopulmonary bypass on neuropsychological functioning. Stroke. 1994 Jul;25(7):1393-9. doi: 10.1161/01.str.25.7.1393.</citation>
    <PMID>8023354</PMID>
  </reference>
  <reference>
    <citation>Riding G, Daly K, Hutchinson S, Rao S, Lovell M, McCollum C. Paradoxical cerebral embolisation. An explanation for fat embolism syndrome. J Bone Joint Surg Br. 2004 Jan;86(1):95-8.</citation>
    <PMID>14765873</PMID>
  </reference>
  <reference>
    <citation>Caillouette JT, Anzel SH. Fat embolism syndrome following the intramedullary alignment guide in total knee arthroplasty. Clin Orthop Relat Res. 1990 Feb;(251):198-9.</citation>
    <PMID>2295174</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>June 28, 2015</last_update_submitted>
  <last_update_submitted_qc>June 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospitals Coventry and Warwickshire NHS Trust</investigator_affiliation>
    <investigator_full_name>Victoria Gibbs</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Embolism</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/NCT02240732
org study id: STCE2.0
nct id: NCT02240732
lead sponsor: 
has dmc: Yes
BACKGROUND In 2012 76,497 primary total knee (TKR) replacements were performed in England,
      Wales and Northern Ireland . Traditionally TKR surgery is undertaken with the aid of a
      surgical tourniquet. A surgical tourniquet is an occlusive device applied around a patient's
      leg. The tourniquet squeezes the leg (including blood vessels within the leg) and can
      therefore reduce the amount of bleeding that occurs while it is inflated. An intraoperative
      tourniquet can therefore help to improve the surgical field of view. Although the majority of
      surgeons prefer to undertake TKR surgery using a tourniquet a small but increasing number are
      now not pursuing these devices.

      There is robust evidence that the risk of deep vein thrombosis is increased if a tourniquet
      is used for TKR surgery. In addition embolic material in the venous system have been observed
      following TKR surgery and have been noted to be present in the right atrium with
      transoesophageal (TOE) echo intra-operatively. , Significant and potentially life threatening
      emboli have been documented to enter the cerebral circulation via pulmonary arterio-venous
      shunts and patent foramen ovale (PFO) (27% of patients at autopsy) , . The clinical
      manifestations of cerebral emboli post tourniquet deflation in TKR are not fully understood.
      Fat embolism syndrome and post-operative confusion in TKR patients may be the result of
      emboli formed during a TKR. ,

      AIM

        -  Is there evidence of emboli entering the cerebral circulation following tourniquet
           deflation in TKR surgery?

        -  Is there evidence of MRI detectable brain lesions and or any clinical change in
           cognition compared in patients undergoing TKR surgery with a tourniquet compared to
           those that do not have a tourniquet?
observational model: Cohort
time perspective: Prospective
measure: Number of Emboli on Transcranial Doppler
time frame: Intra-operative
description: 2 independent technicians will verify the number of emboli detected. Non-invasive
measure: MRI brain scan - presence of Emboli
time frame: Post-operatively, prior to discharge
description: Reviewed by Professor of radiology - presence, number and volume of diffusion weighted lesions
measure: Mini-mental state examination
time frame: Pre-operative vs Post-operative
description: Set of 30 questions which test cognitive function
arm group label: Total knee replacement patients
description: Patients who are due to have a total knee replacement will be studied to look for the presence of Emboli.
Observational with imaging.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Victoria Gibbs, BA, MBBS
role: Principal Investigator
affiliation: UHCW
facility: 
country: United Kingdom
citation: Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
PMID: 21161177
citation: Parmet JL, Horrow JC, Pharo G, Collins L, Berman AT, Rosenberg H. The incidence of venous emboli during extramedullary guided total knee arthroplasty. Anesth Analg. 1995 Oct;81(4):757-62. doi: 10.1097/00000539-199510000-00017.
PMID: 7574006
citation: Parmet JL, Berman AT, Horrow JC, Harding S, Rosenberg H. Thromboembolism coincident with tourniquet deflation during total knee arthroplasty. Lancet. 1993 Apr 24;341(8852):1057-8. doi: 10.1016/0140-6736(93)92414-o.
PMID: 8096961
citation: Arroyo JS, Garvin KL, McGuire MH. Fatal marrow embolization following a porous-coated bipolar hip endoprosthesis. J Arthroplasty. 1994 Aug;9(4):449-52. doi: 10.1016/0883-5403(94)90057-4.
PMID: 7964778
citation: Pugsley W, Klinger L, Paschalis C, Treasure T, Harrison M, Newman S. The impact of microemboli during cardiopulmonary bypass on neuropsychological functioning. Stroke. 1994 Jul;25(7):1393-9. doi: 10.1161/01.str.25.7.1393.
PMID: 8023354
citation: Riding G, Daly K, Hutchinson S, Rao S, Lovell M, McCollum C. Paradoxical cerebral embolisation. An explanation for fat embolism syndrome. J Bone Joint Surg Br. 2004 Jan;86(1):95-8.
PMID: 14765873
citation: Caillouette JT, Anzel SH. Fat embolism syndrome following the intramedullary alignment guide in total knee arthroplasty. Clin Orthop Relat Res. 1990 Feb;(251):198-9.
PMID: 2295174
responsible party type: Principal Investigator
investigator affiliation: University Hospitals Coventry and Warwickshire NHS Trust
investigator full name: Victoria Gibbs
investigator title: Doctor
mesh term: Intracranial Embolism