Study of the effectiveness and safety of treatments to help patients with anaemia recover from major emergency surgery. Perioperative Iron and ESA Intervention Study (POP-I).
- Conditions
- Post-operative anaemiaHaematological Disorders
- Registration Number
- ISRCTN24330080
- Lead Sponsor
- ottingham Clinical Trials Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 2400
1. Age 60 years or older.
2. Hb 80–110g/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.
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 no expected to survive for 30 days.
7. Renal replacement therapy.
8. Immunosuppressive therapy for organ transplant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method