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
About this trial
This is an interventional diagnostic trial for Iron-deficiency
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
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
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
Study of the Prevalence of Iron Deficiency in Elderly Patient in Hospital Environment
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