Critically ill patients with anaemia Haematological Disorders Anaemia
Conditions
Interventions
Patients were randomly assigned to receive:
1. Intravenous (i.v.) iron saccharate alone (control group)
2. i.v. iron saccharate and subcutaneous recombinant human erythropoietin (rHuEPO) 40,000 units
Sponsors
Janssen-Cilag (Greece)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients admitted to the intensive care unit (ICU) in each of the 13 participating centres were evaluated for study eligibility. Inclusion criteria were: 1. Age at least 18 years 2. Hb less than 12 g/dl 3. No iron deficiency defined as transferrin saturation less than 10% and ferritin less than 50 ng/ml 4. Negative pregnancy test (for females in the reproductive age) 5. An expected ICU stay of at least 7 days 6. Provision of signed informed consent The expected duration of the ICU stay was judged on clinical grounds and APACHE II score by the ICU team at admittance to the unit.
Exclusion criteria
Exclusion criteria: 1. Chronic renal failure requiring dialysis 2. New onset (less than 6 months) seizures 3. Life expectancy of less than 7 days 4. Previous use of rHuEPO (within 3 months) 5. Recent use of cytostatics or recent radiotherapy (within 1 month) 6. Participation in another research protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome end-points were: 1. Differences in Hct and Hb between groups 2. Transfusion independence between study day 1 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional data recorded included: 1. ICU length of stay 2. Cumulative mortality through day 28 3. Adverse effects, assessed daily | — |
Countries
Greece
Outcome results
None listed