CarenceMartial: Transferrin Saturation Coefficient and Ferritinemia in Diagnosis of Iron Deficiency

• Sponsor: Lille Catholic University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04139265
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Actual Duration (Months): 3.8
• Patients Per Site Per Month: 35.7

Study Details

Study Description

Brief Summary

Transferrin saturation coefficient and ferritinemia in diagnosis of iron deficiency

Condition or Disease	Intervention/Treatment	Phase
Iron-deficiency; Internal Medicine; Transferrin; Ferritinemia	Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient)

Study Design

• Study Type: Observational
• Actual Enrollment: 136 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jun 6, 2019
• Actual Primary Completion Date: Sep 30, 2019
• Actual Study Completion Date: Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Hospitalized patients aged 65 and over - Patients aged 65 and over hospitalized in the department of Internal Medicine and Geriatry	Diagnostic Test: biologic analysis (ferritinemia, transferrin saturation coefficient); Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis

Outcome Measures

Primary Outcome Measures

1. Agreement between Transferrin Saturation Coefficient (TSC) and ferritinemia dosage [Day one]

   The overall agreement, assessed by kappa Cohen

Secondary Outcome Measures

1. Prevalence of iron deficiency with and without anaemia [Day one]

   Number of patients with iron deficiency with or without anaemia

2. Prevalence of etiologies of iron deficiency [Day one]

   Number of patients for each etiology

3. Prevalence of iron deficiency in patients with anticoagulant and platelet aggregation inhibitor [Day one]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint-Philibert hospital	Lomme	Nord	France	59462

Sponsors and Collaborators

• Lille Catholic University

Investigators

• Principal Investigator: Hélène Bulckaen, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lille Catholic University
• ClinicalTrials.gov Identifier: NCT04139265
• Other Study ID Numbers: RC-P0079
• First Posted: Oct 25, 2019
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia, Iron-Deficiency

Study Results

No Results Posted as of Oct 25, 2019