Use of iron supplement injection (Ferinject) in anaemic patients undergoing heart surgery. Haematological Disorders Iron deficiency anaemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Elective cardiac surgery 3. Pre-operative haemoglobin (Hb) level >1g/dl below the normal range (i.e. women <11.5g/dl and men <12.5 g/dl)
Exclusion criteria
Exclusion criteria: 1. Pregnancy 2. Patient participating in another trial 3. Patients unable to give written consent 4. Patients with a recognised allergy or other contraindication to intravenous iron or related products 5. Low haemoglobin attributable to haemoglobinopathy 6. Anaemia secondary to known co-existing and uncorrected B12 or folate deficiency 7. Patients already receiving oral or intravenous iron treatment 8. Patients with evidence of significant symptomatic anaemia which would normally require urgent transfusion at the time of assessment 9. Patients with a Hb less than 9.0 g/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Haemoglobin (g/dl) increment after intravenous ferric carboxymaltose (Ferinject) 2. Proportion of patients achieving an increase in Haemoglobin level >1.5g/dl pre-op after intravenous ferric carboxymaltose (Ferinject) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Units of blood transfusion post-op (in theatre and CICU) 2. Duration of CICU and In-hospital LOS 3. Rates of post-operative complications (listed above) 4. Change in quality of life 5. Factors associated with anaemia and iron therapy i.e. serum ferritin, sTFR, iron, transferring, CRP, erythropoietin (EPO) and iron binding capacity, hepcidin 6. Cost savings | — |
Countries
United Kingdom