Iron-deficiencyCarenceMartialNCT04139265
Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency
An observational study of Iron-deficiency and Internal Medicine, run by Lille Catholic University at 1 site in France.
Trial summary
Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Iron-deficiency, Internal Medicine, Transferrin
- What is being tested?
- biologic analysis (ferritinemia, transferrin saturation coefficient)
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jun 2019to 30 Sep 2019
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly people hospitalized in the internal medicine and geriatry service
Who may be able to join
- ≥ 65 years old
- Patient hospitalized in the internal medicine and geriatry service
- Patient affiliated with a social security scheme
- Patient signed an Informed consent
Who cannot join
- Risk benefit balance not in favor of iron deficiency check-up
- Patient in palliative care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accordance Between Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency, in Patients Hospitalised in Internal Medicine Service and 65 Years Old and More
Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency
- Conditions
- Iron-deficiency, Internal Medicine, Transferrin, Ferritinemia
- Being tested
- biologic analysis (ferritinemia, transferrin saturation coefficient)
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic analysis (ferritinemia, transferrin saturation coefficient)Diagnostic test
Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients aged 65 and over | - Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry Receives: Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage
The overall agreement, assessed by kappa Cohen
Measured: Day one
Secondary outcomes (3)
Prevalence of iron deficiency with and without anaemia
Number of patients with iron deficiency with or without anaemia
Measured: Day one
Prevalence of etiologies of iron deficiency
Number of patients for each etiology
Measured: Day one
Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start6 Jun 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène Bulckaen, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139265
- Sponsor's protocol ID
- RC-P0079
- Acronym
- CarenceMartial
- Status last verified
- Oct 2019
- First submitted
- 23 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No