An observational study in Anemia, Post ICU Syndrome and Red Blood Cell Transfusions, sponsored by Università degli Studi di Ferrara. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.
Sponsored by Università degli Studi di Ferrara · Observational
IRON-RECOVERY is a prospective, multicenter, observational cohort study designed to determine the prevalence of iron deficiency at intensive care unit (ICU) discharge and to evaluate its association with post-ICU clinical recovery.
Anemia is highly prevalent in critically ill patients and frequently persists after ICU discharge. Although inflammation-induced iron dysregulation is considered one of the main mechanisms underlying persistent anemia, iron deficiency remains largely under-recognized in this population because conventional biomarkers, particularly ferritin, are influenced by the inflammatory response. Transferrin saturation (TSAT) has emerged as a more reliable marker of iron availability and may better identify patients with iron-restricted erythropoiesis.
Adult patients admitted to participating ICUs for at least 72 hours will undergo assessment of iron status at ICU discharge using routine laboratory tests, including hemoglobin, serum iron, transferrin, ferritin, TSAT, and inflammatory markers. When available, admission iron parameters will also be collected to evaluate changes during the ICU stay. No study-specific therapeutic intervention will be mandated, and all treatment decisions, including intravenous iron administration, will remain at the discretion of the treating physicians.
The primary objective is to determine the prevalence of iron deficiency (defined as TSAT \<20%) at ICU discharge. Secondary objectives include evaluating the association between iron deficiency and post-ICU red blood cell transfusion requirements, hemoglobin recovery, functional status assessed by EQ-5D, hospital readmission, mortality, and days alive and out of hospital. Exploratory analyses will assess the association between intravenous iron therapy and clinical outcomes after adjustment for confounding factors. Also, risk factors for ICU-acquired iron deficiency will be investigated.
The findings of this study are expected to provide the first prospective multicenter estimate of iron deficiency at ICU discharge and to inform the design of future interventional trials evaluating iron replacement as part of post-ICU patient blood management strategies.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's planned enrollment of 462 is above the median of 270 across 368 observational studies indexed under Anemia.
Browse Anemia studies →Università degli Studi di Ferrara is the lead sponsor of 65 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All critically ill patients alive at ICU discharge
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Exclusion criteria:
All critically ill patients are eligible for the study
Diagnostic Test: transferrin saturation
All patients will be tested for absolute or relative iron deficiency
Also known as: EQ-5D questionnaire
Iron deficiency
iron deficiency will be defined as: TSAT \<20%, regardless of ferritin levels and/or Ferritin \<100 ng/mL
Time frame: The day of ICU discharge (day 1)
Iron deficiency at ICU admission
iron deficiency will be defined as: TSAT \<20%, regardless of ferritin levels and/or Ferritin \<100 ng/mL
Time frame: ICU admission
Proportion of patients receiving RBCT after ICU discharge
Proportion of patients receiving RBCT after ICU discharge
Time frame: 30-day
Hemoglobin level 28 days after ICU discharge
Hemoglobin level at hospital discharge and/or 28 days after ICU discharge
Time frame: up to 28-days after ICU discharge
Functional recovery
assessed using the EQ-5D questionnaire
Time frame: up to 90-day after ICU discharge
Hospital readmission
Percentage of hospital readmission
Time frame: up to 180-days after ICU discharge
Mortality
30-day mortality
Time frame: 30-day
mortality
90-day mortality
Time frame: 90-day
mortality
180-days mortality
Time frame: 180-day
Plan to share: Yes — IPD will be shared under reasonable requests
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
Of 124 non-industry observational studies under Anemia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 84. This study's planned 12 months is below that.
Counting every sponsor, half of 145 studies reached it within 30 months; a quarter within 12 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
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Università degli Studi di Ferrara