<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/NCT02969811</url>
  </required_header>
  <id_info>
    <org_study_id>AC16087</org_study_id>
    <nct_id>NCT02969811</nct_id>
  </id_info>
  <brief_title>Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur</brief_title>
  <official_title>Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study</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>
      Blood transfusion is an expensive and finite resource and optimum transfusion threshold in&#xD;
      surgical patients is yet to be defined. Patients commonly receive blood transfusions to&#xD;
      reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the&#xD;
      kidneys), but this treatment may have important adverse effects including postoperative&#xD;
      infection. Patients undergoing surgery for fractured neck of femur are often elderly, with&#xD;
      co-morbidities and a high risk of postoperative complications, including MI and AKI. We&#xD;
      propose to conduct a study with the following aims:&#xD;
&#xD;
        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for&#xD;
           fractured neck of femur.&#xD;
&#xD;
        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac&#xD;
           and kidney injury in this group.&#xD;
&#xD;
        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints&#xD;
           in a future prospective randomised trial of perioperative transfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood transfusion is an expensive and finite resource and optimum transfusion threshold in&#xD;
      surgical patients is yet to be defined. Patients commonly receive blood transfusions to&#xD;
      reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the&#xD;
      kidneys), but this treatment may have important adverse effects including postoperative&#xD;
      infection. There is great interest in restrictive transfusion practices (e.g. a transfusion&#xD;
      trigger of 70 g L-1), however patients with co-existing cardiovascular disease have been&#xD;
      excluded from studies of restrictive versus liberal transfusion strategies. Highly sensitive&#xD;
      troponin assays are now available, which allow clinicians to reliably detect cardiac injury&#xD;
      in increased numbers of patients who have undergone major surgery. Troponin release after&#xD;
      surgery is common, as high as 40% in some studies. Patients undergoing surgery for fractured&#xD;
      neck of femur are often elderly, with co-morbidities and a high risk of postoperative&#xD;
      complications, including MI and AKI. We propose to conduct a study with the following aims:&#xD;
&#xD;
        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for&#xD;
           fractured neck of femur.&#xD;
&#xD;
        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac&#xD;
           and kidney injury in this group.&#xD;
&#xD;
        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints&#xD;
           in a future prospective randomised trial of perioperative transfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>Cardiac Injury</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>Serum Troponin above upper reference limit</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Anaemia, Myocardial Ischaemia, Fractured Neck of Femur</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have suffered fractured neck of femur.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fractured Neck of Femur&#xD;
&#xD;
          -  Age &gt;50&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael A Gillies, MD</last_name>
    <phone>0131 242 3193</phone>
    <email>Michael.Gillies@nhslothian.scot.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alastair Lang, RN</last_name>
    <phone>0131 536 1000</phone>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Neck Fractures</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/NCT02969811
org study id: AC16087
nct id: NCT02969811
lead sponsor: 
has dmc: No
Blood transfusion is an expensive and finite resource and optimum transfusion threshold in
      surgical patients is yet to be defined. Patients commonly receive blood transfusions to
      reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the
      kidneys), but this treatment may have important adverse effects including postoperative
      infection. Patients undergoing surgery for fractured neck of femur are often elderly, with
      co-morbidities and a high risk of postoperative complications, including MI and AKI. We
      propose to conduct a study with the following aims:

        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for
           fractured neck of femur.

        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac
           and kidney injury in this group.

        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints
           in a future prospective randomised trial of perioperative transfusion.
Blood transfusion is an expensive and finite resource and optimum transfusion threshold in
      surgical patients is yet to be defined. Patients commonly receive blood transfusions to
      reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the
      kidneys), but this treatment may have important adverse effects including postoperative
      infection. There is great interest in restrictive transfusion practices (e.g. a transfusion
      trigger of 70 g L-1), however patients with co-existing cardiovascular disease have been
      excluded from studies of restrictive versus liberal transfusion strategies. Highly sensitive
      troponin assays are now available, which allow clinicians to reliably detect cardiac injury
      in increased numbers of patients who have undergone major surgery. Troponin release after
      surgery is common, as high as 40% in some studies. Patients undergoing surgery for fractured
      neck of femur are often elderly, with co-morbidities and a high risk of postoperative
      complications, including MI and AKI. We propose to conduct a study with the following aims:

        1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for
           fractured neck of femur.

        2. To use clinical and biochemical data to measure the incidence of perioperative cardiac
           and kidney injury in this group.

        3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints
           in a future prospective randomised trial of perioperative transfusion.
observational model: Cohort
time perspective: Prospective
measure: Cardiac Injury
time frame: 72 hours after surgery
description: Serum Troponin above upper reference limit
Blood, Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Michael A Gillies, MD
phone: 0131 242 3193
email: Michael.Gillies@nhslothian.scot.nhs.uk
last name: Alastair Lang, RN
phone: 0131 536 1000
responsible party type: Sponsor
mesh term: Myocardial Ischemia
mesh term: Anemia
mesh term: Ischemia
mesh term: Fractures, Bone
mesh term: Femoral Neck Fractures