Study name: POP-I Status: Setup
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)
Professor Iain Moppett, Nottingham Universtiy Hospitals NHS Trust
What is the study about?
Each year in the UK over 100,000 people over 60 years of age are admitted to hospital for lifesaving emergency operations, such as hip fracture and abdominal surgery. Many of these people develop anaemia (a reduced number of red blood cells) after their operation. Patients who develop anaemia have a slower recovery, more complications, and therefore spend more time in hospital.
Anaemia can be treated with drugs such as iron and darbepoetin, but whether this improves recovery, survival and the general health of people who have undergone an emergency operation is not known.
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 be assigned randomly to one of three study groups:
- Usual care for anaemia.
- Usual care for anaemia + iron infusion.
- Usual care for anaemia + iron infusion + darbepoetin injection.
We will also measure quality of life, safety, and cost or savings associated with either of the treatments.
Who can take part in the trial?
Patients aged 60 or over who have developed anaemia after having undergone either hip fracture surgery or emergency laparotomy,
What is being tested in the trial?
We are testing two treatments:
- Iron infusion given through an IV drip
- Iron infusion given through an IV drip + Darbepoetin injection
What is this being compared to?
We are comparing the two treatments to 'usual care’ for patients who develop anaemia after surgery. Please note that all patients, including those who receive the treatments listed above, will receive usual care.
What are we trying to find out?
We are trying to find out if patients in the study who receive a treatment spend less time at hospital and more time at home after surgery.
How many patients do we need?
2400 patients recruited from 40 hospitals.
National Institute of Health Research
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