<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/NCT03810092</url>
  </required_header>
  <id_info>
    <org_study_id>CHD117-17</org_study_id>
    <nct_id>NCT03810092</nct_id>
  </id_info>
  <brief_title>Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur</brief_title>
  <acronym>PAAF</acronym>
  <official_title>Analysis of the Relationship Between Early Postoperative Anemia and the Evolution of Autonomy at 6 Months in Patients 75 Years of Age and Older Operated on Following a Fracture of the Upper End of the Femur</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Departemental Vendee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Departemental Vendee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fracture of the upper extremity of the femur is a condition whose frequency increases with&#xD;
      age. It is a serious disease, with multiple consequences such as a decrease in life&#xD;
      expectancy, quality of life and patient autonomy. In this observational study, the&#xD;
      investigators wish to evaluate the evolution of the autonomy of very elderly patients&#xD;
      operated on for an upper extremity femur fracture as a function of early post-operative&#xD;
      anemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2019</start_date>
  <completion_date type="Actual">April 12, 2023</completion_date>
  <primary_completion_date type="Actual">April 12, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin rate</measure>
    <time_frame>5 days after surgery</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire Activities of Daily Living</measure>
    <time_frame>Pre-fractural and 6 months after surgery</time_frame>
    <description>For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.&#xD;
A loss of autonomy will be defined by the decrease of one or more points in the ADL.</description>
  </primary_outcome>
  <enrollment type="Actual">255</enrollment>
  <condition>Femoral Fracture</condition>
  <eligibility>
    <study_pop>
      <textblock>
        This study is intended for patients over 75 years of age who have had a fracture of the&#xD;
        upper extremity of the femur operated on.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 75 years&#xD;
&#xD;
          -  Patient operated on a fracture of the upper extremity of the femur&#xD;
&#xD;
          -  Patient, family or close relative who does not object to participation in the study&#xD;
&#xD;
          -  Patient affiliated to a social security system&#xD;
&#xD;
          -  Patient who can be monitored as part of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate in the study (patient, family or trusted relative)&#xD;
&#xD;
          -  Patient with support on the operated limb not authorized by the surgeon&#xD;
&#xD;
          -  Patient with an associated fracture (polytrauma, concomitant trauma to the upper&#xD;
             limb...)&#xD;
&#xD;
          -  Patient with a pathologic fracture&#xD;
&#xD;
          -  Patient included in Category 1 interventional research (involving a drug or medical&#xD;
             device)&#xD;
&#xD;
          -  Patient deprived of liberty&#xD;
&#xD;
          -  Patient not affiliated to a social security system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romain DECOURS</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHD Vendée</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Cholet</name>
      <address>
        <city>Cholet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental Vendée</name>
      <address>
        <city>La Roche sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH La Rochelle</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint Malo</name>
      <address>
        <city>Saint-Malo</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</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>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03810092
org study id: CHD117-17
nct id: NCT03810092
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Fracture of the upper extremity of the femur is a condition whose frequency increases with
      age. It is a serious disease, with multiple consequences such as a decrease in life
      expectancy, quality of life and patient autonomy. In this observational study, the
      investigators wish to evaluate the evolution of the autonomy of very elderly patients
      operated on for an upper extremity femur fracture as a function of early post-operative
      anemia.
observational model: Other
time perspective: Prospective
measure: Hemoglobin rate
time frame: 5 days after surgery
measure: Questionnaire Activities of Daily Living
time frame: Pre-fractural and 6 months after surgery
description: For each question, a point from 0 (worst value) to 1 (best value) is assigned. The total score is 6 points.
A loss of autonomy will be defined by the decrease of one or more points in the ADL.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Romain DECOURS
role: Principal Investigator
affiliation: CHD Vendée
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: No