Peri-op Iron and EPO Intervention Study (POP-I)
Research type
Research Study
Full title
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).
IRAS ID
1007432
Contact name
Iain Moppett
Contact email
Sponsor organisation
University of Nottingham
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Each year over 100,000 people over 60 years of age in the UK are admitted to hospital for lifesaving emergency operations. Two of the most common emergency operations are for hip fracture and severe abdominal problems. Many of these people have anaemia (a reduced number of red blood cells). Anaemia increases the risk of dying after surgery and those that do survive have a slower recovery, more complications, and therefore spend more time in hospital. Anaemia can be treated with drugs such as iron, but whether this improves survival and the general health of people who require an emergency operation is not known.
Our aim is to improve outcomes for people who are anaemic following emergency surgery, and to determine the cost-effectiveness of drug treatment for anaemia compared with usual care. One treatment option is a single infusion of iron, given through a drip. Another treatment option is to give iron plus an Erythropoiesis-Stimulating-Agent (ESA) called darbepoetin. An ESA works in combination with iron to increase the production of red blood cells and improve the blood count. This works in combination with iron to improve anaemia. Research in other groups of patients, such as those with heart and kidney problems, has shown that both treatments work very well. However, we do not know whether they would help patients recovering from emergency surgery.
We have designed a study to investigate whether treating anaemia after emergency surgery leads to people having more days at home after their operation. The study will recruit patients who have had different types of emergency surgery for abdominal problems or hip fracture. These patients will enter the study 1–10 days after their emergency operation and then assigned randomly (by chance) to one of three study groups: 1: usual care, 2: usual care+iron infusion 3: Usual care+iron infusion+ESA injection. We will also measure quality of life, safety, and cost or savings associated with either of the treatments.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0425
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion