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Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment (CARENFERPA)

Primary Purpose

Iron-deficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Vifor Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Iron-deficiency

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient hospitalized in a geriatric unit (short geriatric stay, SSR) or seen on an outpatient basis (hospitalization day, consultation)
  • Affiliated patient or beneficiary of a social healthcare system
  • Patient having given written consent

Exclusion Criteria:

  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Blood sampling

    Arm Description

    Blood sampling

    Outcomes

    Primary Outcome Measures

    Percentage of patients diagnosed with iron deficiency on inclusion
    The diagnosis of iron deficiency will be made from the measurements of the ferritinemia and CST: Ferritinemia < 100 µg/L and/or CST < 20%

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2022
    Last Updated
    November 7, 2022
    Sponsor
    Vifor Pharma
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05514951
    Brief Title
    Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment
    Acronym
    CARENFERPA
    Official Title
    Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2022 (Anticipated)
    Study Completion Date
    November 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Vifor Pharma

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Iron deficiency is defined by insufficient tissue iron stores and anemia is the ultimate stage of iron deficiency. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient.
    Detailed Description
    Iron deficiency (MD) is defined by insufficient tissue iron stores. Since iron is essential for the synthesis of hemoglobin, when the iron deficiency no longer makes it possible to maintain a sufficient level of erythropoiesis, anemia appears: it is the ultimate stage of iron deficiency. Anemia is the most common haematological pathology encountered in geriatric practice. Its prevalence, in population generally ambulatory, is between 10 and 15% after the age of 65 and is greater than 20% beyond the age of 85. Anemia should never be neglected in an elderly subject because it is associated with an increase in mortality, but also with a increased morbidity in terms of complications heart disease, cognitive decline, frailty, hospitalizations, and impairment of quality of life. About a third of anemias elderly person is attributable to a deficiency in vitamin B9 or B12 or an iron deficiency. Apart from anemia, iron deficiency is common and constitutes a factor of poor prognosis in diseases chronic such as heart failure, kidney failure chronic or cancer, all pathologies very frequently found in the elderly. It is the origin of the deterioration in the general condition of patients, their re-hospitalization or even the progression of their pathology. In this context where elderly patients also present a certain number of comorbidities including the pathologies mentioned previously, it is important to better diagnose the deficiency martial in the elderly patient. This diagnosis is all the more important because, depending on the chronic pathology, data from the literature have shown that correcting the iron deficiency brings benefits to the patient by reducing the risk of recurrence of anemia, the prescription of erythropoietin and the use of transfusion for patients in oncology, gastroenterology and nephrology

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron-deficiency

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    900 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Blood sampling
    Arm Type
    Experimental
    Arm Description
    Blood sampling
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Blood sampling
    Intervention Description
    Blood sampling
    Primary Outcome Measure Information:
    Title
    Percentage of patients diagnosed with iron deficiency on inclusion
    Description
    The diagnosis of iron deficiency will be made from the measurements of the ferritinemia and CST: Ferritinemia < 100 µg/L and/or CST < 20%
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any patient hospitalized in a geriatric unit (short geriatric stay, SSR) or seen on an outpatient basis (hospitalization day, consultation) Affiliated patient or beneficiary of a social healthcare system Patient having given written consent Exclusion Criteria: Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by court order or administration
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Serge MAILLET
    Phone
    + 33 1 80 04 16 39
    Email
    serge.maillet@viforpharma.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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