The clinical benefits and cost effectiveness and safety of haematopoietic interventions for patients with anaemia following major emergency surgery: a phase IV, multisite, multi-arm randomised controlled trial: Peri-op Iron and EPO Intervention Study (POP-I).

ottingham Clinical Trials Unit0 个研究点目标入组 2,400 人开始时间: 2023年10月20日最近更新: 2023年11月13日

适应症

试验速览

暂无简介。

•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

发起方

ottingham Clinical Trials Unit