Anaemic survivors of critical illness defined as patients who have received Intensive Care Society Level 2 or 3 care who are ready for discharge from Critical Care (i.e. an ICU or HDU in the UK) who are have mild or moderate anaemia (plasma haemoglobin =100 g/L prior to ICU/HDU discharge) Haematological Disorders
Conditions
Interventions
Participants will be randomised using an online database to the intervention intravenous ferric carboxymaltose 1000 mg and subcutaneous darbepoetin alfa 150 mcg) or the comparator (equal volume of 0.9
Sponsors
University of Edinburgh & NHS Lothian ACCORD
Eligibility
Sex/Gender
All
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Adults (=16 years) who required =24 hours critical care (defined as requiring level 3 or level 2* care at ICU admission) and are considered fit for ICU or HDU discharge by caring consultant/clinician. 2. Most recently available laboratory Hb =100 g/L prior to ICU/HDU discharge. 3. Provision of informed consent. *Levels of Adult Critical Care, Consensus Statement, Intensive Care Society https://ics.ac.uk/resource/levels-of-care.html
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 29/10/2025: 1. Acute uncontrolled infection – defined as ongoing bacteraemia and/or patient expected to be on non-prophylactic antibiotics for greater than 14 days from the date of eligibility assessment. 2. Cancer (known or suspected malignant disease and has not completed a course of curative treatment). 3. IV iron and/or rHuEPO in the last 30 days. 4. Severe chronic liver disease (defined by a Child-Pugh grade of C). 5. Patient is known to be pregnant. (a pregnancy test in individuals with childbearing potential will be performed prior to enrolment and patients who are pregnant will be excluded). 6. Diagnosis of haemochromatosis or secondary iron overload disorder. 7. Immunosuppression for organ transplant. 8. Primary neurological diagnosis and/or severe traumatic brain injury. 9. Admission to ICU following elective cardiac surgery. 10. Known hypersensitivity to iron and/or rHuEPO. 11. History of pure red cell aplasia following erythropoietin therapy. 12. Thromboembolism chemoprophylaxis is contraindicated. 13. Patient receiving palliative or end-of-life care. 14. Known allergy to derivative of latex. Previous exclusion criteria: 1. Acute uncontrolled infection – defined as ongoing bacteraemia and/or patient expected to be on non-prophylactic antibiotics for greater than 14 days from the date of eligibility assessment. 2. Cancer (known or suspected malignant disease and has not completed a course of curative treatment). 3. IV iron and/or rHuEPO in the last 30 days. 4. Severe chronic liver disease (defined by a Child-Pugh score of 3). 5. Patient is known to be pregnant. (a pregnancy test in individuals with childbearing potential will be performed prior to enrolment and patients who are pregnant will be excluded). 6. Diagnosis of haemochromatosis or secondary iron overload disorder. 7. Immunosuppression for organ transplant. 8. Primary neurological diagnosis and/or severe traumatic brain injury. 9. Admission to ICU following elective cardiac surgery. 10. Known hypersensitivity to iron and/or rHuEPO. 11. History of pure red cell aplasia following erythropoietin therapy. 12. Thromboembolism chemoprophylaxis is contraindicated. 13. Patient receiving palliative or end-of-life care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical aspects of health-related quality of life measured using the physical component summary of the SF-36 health-related quality of life (HRQoL) questionnaire (PCS) completed by patients at 90 days post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/10/2025: Patient-centred outcomes: 1. The physical health components of health-related quality of life are measured using the PCS completed by patients at 30 days post-randomisation. 2. The mental health components of health-related quality of life are measured using the mental component summary of the SF-36 health-related quality of life (HRQoL) questionnaire (MCS) completed by patients at 30 and 90 days post-randomisation. 3. Fatigue is measured using the Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) questionnaire completed by patients at 7 and 90 days post-randomisation. 4. Days spent by patients outside a healthcare facility measured using Days Alive and at Home (DAH) at 30 and 90 days post-randomisation which will be calculated from vital status, date of death, days spent in hospital prior to discharge and hospital readmission days at 30 and 90 days post-randomisation. 5. Red blood cell transfusion measured by totalling the number of red blood cell units transfused during the first 90 days post-randomisation. 6. Hospital readmissions measured using medical records and include the number of hospital readmissions and the total number of days during hospital readmissions. 7. Mortality ascertained from medical records at 30 and 90 days. Safety outcomes: 1. New clinically important infection up to hospital discharge: new post-ICU infection (new initiation of IV antibiotics or IV antivirals for suspected or confirmed infection between ICU and hospital discharge) ascertained from medical records. 2. Clinically important infection after hospital discharge up to 90 days: new initiation of IV antibiotics or IV antivirals between hospital discharge and the 90-day follow-up mentioned by patients in a safety questionnaire administered at 30 and 90 days after randomisation. 3. Thromboembolic event up to hospital discharge: clinically diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) ascertained | — |
Countries
England, United Kingdom
Contacts
Public ContactFiach O’Mahony
Outcome results
None listed