Iron deficiency anaemia
Conditions
Interventions
Two groups:Iron Isomaltoside 1000 Inj. (100mg/ml and 500mg/5mls), Intravenous infusion 20mg/kg (50kg BW) single +/- second dose 2 weeks later (in time frame of 3-10 weeks before operation) versus Stan
Sponsors
Department of Anaesthesia and Intensive Care, PWH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >18 years old with written informed consent; 2. Anaemia defined as: hemoglobin concentration <13g/dL; 3. Laboratory test confirmed iron deficiency: serum ferritin <30mcg/L alone or serum ferritin 30-100mcg/L with TSAT < 20%.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation; 2. Other known causes of anaemia apart from iron deficiency: untreated B12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis; 3. Presence of iron overload (serum ferritin > 300g/dL or TSAT > 50%); known hemochromatosis; 4. Previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment; 5. Known hypersensitivity towards iron isomaltoside; 6. Significant liver function derangement (AST/ALP exceeding three times upper limit of normal range); 7. Use of preoperative immunosuppressant therapy; 8. Participation in another ongoing interventional clinical trial(s); 9. Patients with less than 3 weeks waiting time to surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative change in hemoglobin concentration;Preoperative change in serum ferritin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Units of red blood cells transfused in perioperative period;Duration of hospital stay;Quality of recovery as measured by questionnaire (QoR-15(Chinese);Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions;Rate of surgical complications;Days (alive and) at home within 30 days of surgery (DAH30); | — |
Countries
China
Contacts
Public ContactDr. FUNG Pui Lam Polly
Resident, Department of Anaesthesia and Intensive Care, PWH
Outcome results
None listed