University Hospital, Grenoble Alpes
La Tronche, 38700, France
Location contact
Alexis BOCQUET, Hospital Doctor
PRINCIPAL_INVESTIGATOR
Bruna DUCOTTERD, Clinical Research Associate
CONTACT
NCT Number: NCT07014436
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
La Tronche, 38700, France
Alexis BOCQUET, Hospital Doctor
PRINCIPAL_INVESTIGATOR
Bruna DUCOTTERD, Clinical Research Associate
CONTACT
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 3 months (end of study)
The improvement in anemia, represented by the mean hemoglobin level (g/L) measured at 3 months after hospitalization, between patients who received iron supplementation and those who did not.
Time frame: At 3 months (end of study)
Proportion of patients having corrected their anemia (hemoglobin level ≥ 13 g/dL in men, ≥ 12 g/dL in women).
Time frame: At 3 months (end of study)
Analysis of demographic (age, gender), clinical (comorbidities) and biological factors
Time frame: At 3 months (end of study)
Incidence of adverse effects associated with iron supplementation (hypersensitivity, iron overload).
Contact information is provided by the study sponsor or research team.
University Hospital, Grenoble
Other
Acronym: CARMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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