- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04139265
Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency (CarenceMartial)
October 23, 2019 updated by: Lille Catholic University
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
136
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nord
-
Lomme, Nord, France, 59462
- Saint-Philibert hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
63 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly people hospitalized in the internal medicine and geriatry service
Description
Inclusion Criteria:
- ≥ 65 years old
- Patient hospitalized in the internal medicine and geriatry service
- Patient affiliated with a social security scheme
- Patient signed an Informed consent
Exclusion Criteria:
- Risk benefit balance not in favor of iron deficiency check-up
- Patient in palliative care
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hospitalized patients aged 65 and over
- Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry
|
Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage
Time Frame: Day one
|
The overall agreement, assessed by kappa Cohen
|
Day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of iron deficiency with and without anaemia
Time Frame: Day one
|
Number of patients with iron deficiency with or without anaemia
|
Day one
|
Prevalence of etiologies of iron deficiency
Time Frame: Day one
|
Number of patients for each etiology
|
Day one
|
Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor
Time Frame: Day one
|
Day one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hélène Bulckaen, MD, Groupement des Hôpitaux de l'institut Catholique de Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2019
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
October 23, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (Actual)
October 25, 2019
Study Record Updates
Last Update Posted (Actual)
October 25, 2019
Last Update Submitted That Met QC Criteria
October 23, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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