Postoperative anaemia Haematological Disorders
Conditions
Interventions
The trial objective is to assess the clinical effectiveness of postoperative intravenous iron and intravenous iron plus a subcutaneous injection of an Erythropoiesis Stimulating Agent (ESA) compared t
National Emergency Laparotomy Audit (NELA) (emergency laparotomy)
Best Practice Tariff (emergency laparotomy and hip fracture).
2. Iron Monotherapy consists of usual care (as above) plus intravenous Ferric Derisomaltose (approximately 20 mg/kg as a single dose befo
Sponsors
Nottingham Clinical Trials Unit
Eligibility
Sex/Gender
All
Age
60 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 60 years or older. 2. Hb 80–110 g/l measured on any day between day 1 and day 10 after surgery. 3. Major non-elective surgery in the last 1 to 10 days: Patient will have undergone either Emergency Laparotomy as defined by National Emergency Laparotomy Audit (NELA) OR Fragility Hip Fracture surgery as defined by National Hip Fracture Database (NHFD). • Written informed consent from participant or personal legal representative.
Exclusion criteria
Exclusion criteria: 1. Use of intravenous iron, darbepoetin or other ESAs in last 30 days 2. Haematological diagnoses where iron overload is a risk (e.g., haemochromatosis or alpha-thalassaemia trait) or alternative treatments are indicated (e.g., haematological malignancies) 3. Acute uncontrolled infection as judged by the treating clinician (e.g. ongoing bacteraemia or non-resolving sepsis) or patient expected to be on non-prophylactic antibiotics for greater than 14 days 4. Contraindication to thromboprophylaxis 5. Direct contraindications to IMP: 5.1. Disturbances of iron, iron overload 5.2. Uncontrolled hypertension 5.3. Red cell aplasia 5.4. Decompensated/severe chronic liver disease (Child Pugh C) 5.5. Advanced cancer (metastatic and/or receiving chemo/radiotherapy) 6. Patient not expected to survive for 30 days 7. Renal replacement therapy 8. Immunosuppressive therapy for organ transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days at home at 30 days (DAH30). Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), DAH30 is an integer between 0 and 30 that reflects, out of the 30 days following randomisation, the total number of those days that the participant spends alive and at home. DAH30 is derived by subtracting from 30 the duration of initial length of stay following randomisation, as well as the duration of any further readmissions (to hospital or elsewhere) in the first 30 days. All days spent not at home, other than holidays, are also subtracted. These include moving house to more dependent living, time spent with relatives, etc. If a participant never returns home or dies at any point within the first 30 days, they will be assigned a score of 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. EQ-5D-5L. Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), the EuroQol-5 Dimension-5 Level (EQ-5D-5L) health status measure is a widely used generic instrument for describing and valuing health states. Measured at baseline, day 30, day 120. 2. NHFD Residential Status. Obtained from medical records at discharge. Categorised using the same ordinal scale as used by the NHFD: (1) own home/sheltered housing, (2) residential care, (3) nursing care, (4) rehabilitation unit – hospital bed in the current trust, (5) rehabilitation unit – hospital bed in another trust, (6) rehabilitation unit – NHS funded care home bed, and (7) acute hospital. Measured at discharge, day 30, day 120. 3. Walking Performance. Reported by participants or their personal legal representative or other person with close knowledge of the participant (e.g. staff from a nursing home), using the ‘New Mobility Score’, which has been utilised by the National Hip Fracture Database (NHFD). Measured at day 30, day 120. 4. Length of Stay. Length of stay is an integer that describes the number of days a patient was in hospital following randomisation. Calculated by obtaining the date of discharge from hospital records and then counting the number of nights between this date and the date of randomisation (obtained from study records). Measured at discharge, day 30, day 120. 5. Complications. Medical records for all patients will be reviewed by appropriately trained staff for indicators of infection at the time of the patient’s discharge from the recruiting site. In addition, for those patients who have left hospital, the patients will self-report (via an online form, telephone interview or by post, at 30 and 120 days after randomisation) on any of the complications listed below. For those patients lacking capacity, their personal legal representative or other person with close knowledge of the participant | — |
Countries
England, United Kingdom
Outcome results
None listed