Prospective Cohort Study Evaluating Iron Supplementation in Patients With Altered Iron Status in the Context of Acute Inflammation (CARMI (CARence Martiale & Inflammation))

Grenoble Alpes University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Anemia; Inflammation

Study type: Observational

Funder types: Other

Identifiers

NCT07014436

38RC25.0094

Details and patient eligibility

About

This study is a prospective, single center, open label cohort study evaluating iron supplementation in patients with impaired martial status in the acute inflammatory setting.

The main objective of this study is to evaluate the effectiveness of iron supplementation in anemic patients with inflammation and an altered iron status in the 'grey zone,' defined by a ferritin level between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) of less than 20%, in the patient internal medicine/general medicine unit of the Grenoble Alpes University Hospital.

The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation.

We hypothesize that iron supplementation more effectively improves hemoglobin levels at three months compared to no supplementation in patients with anemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%) in the context of acute inflammation.

Full description

The main objective of this study is to evaluate the effectiveness of iron supplementation in anaemic patients with inflammation and an altered iron status.

The primary endpoint is the difference in hemoglobin levels at 3 months after hospital discharge between patients treated with or without martial supplementation, and our hypothesis is that iron supplementation improves hemoglobin levels at three months compared to no supplementation in patients with anaemia and altered iron status (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%) in the context of acute inflammation.

The secondary objectives are to evaluate the effectiveness of iron supplementation in anaemic and inflammatory patients with iron status in the "grey zone" (ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20%), to identify demographic, clinical, and biological factors associated with the correction of anaemia in the iron-treated group, to identify demographic, clinical, and biological factors associated with the correction of anaemia in the non-iron-treated group and to assess the safety of iron supplementation.

Anemic patients (hemoglobin < 13 g/dL in men and < 12 g/dL in women), with inflammation (CRP > 30 mg/L), and iron status in the "grey zone" (ferritin between 30 and 300 µg/L and transferrin saturation < 20%) within the first three days of hospitalization are observed according to the iron supplementation strategy chosen as part of their routine care, allowing for a retrospective classification into two groups:

• Group A: patients who received iron supplementation despite having ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) < 20%.
• Group B: patients who did not receive iron supplementation despite ferritin between 30 and 300 µg/L and transferrin saturation coefficient (TSC) < 20%.

Sociodemographic and clinical data of the patients in each group will be collected to control for potential confounding factors in the statistical analysis.

Patients are included the day before or at the end of their hospital stay, once all medical decisions-including whether or not to administer iron-have been made independently of the study. No influence is exerted on therapeutic choices, which are based solely on the routine practices of hospital physicians.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Anemia (Hb < 130 g/L in men and < 120 g/L in women) within the first 3 days of hospitalization in the department
• Biological signs of inflammation (CRP ≥ 30 mg/L) within the first 3 days of hospitalization in the department
• Ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) < 20% within the first 3 days of hospitalization in the department

Exclusion Criteria :

• Patients who object to the use of their data for research purposes
• Patients unable to provide informed consent to participate in the research
• Patients who received a red blood cell transfusion during hospitalization or in the month prior
• Patients receiving erythropoietin (EPO) treatment
• Patients treated with iron supplementation within one month prior to hospitalization
• Congenital hemoglobinopathy (e.g., thalassemia, sickle cell disease)
• Chemotherapy within the past 3 months or planned chemotherapy within the next 3 month

Trial design

100 participants in 2 patient groups

Group A (iron supplementation)

Description:

Patients who have received oral or IV iron as part of routine care for a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) \< 20%.

Group B (without iron supplementation)

Description:

Patients who did not receive iron, despite a ferritin between 30 and 300 µg/L and a transferrin saturation coefficient (TSC) \< 20%.