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 sites2,400 target enrollmentOctober 20, 2023

Overview

No summary available.

Registry

who.int

Start Date

October 20, 2023

End Date

November 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ottingham Clinical Trials Unit

•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)