POP-I is short for Peri-op Iron and Erythropoietin (EPO) Intervention Study, it is a phase IV, multisite, multi-arm randomised controlled trial to access the clinical effectiveness of postoperative intravenous iron and intravenous iron plus a subcutaneous injection of an Erythropoiesis Stimulating Agent (ESA) compared to a usual care control group respectively, for the treatment of anaemia across two major patient groups who have had emergency surgery. Our target population is adults aged 60 years or over with mild or moderate anaemia (Hb 80–110g/l) after either hip fracture surgery or emergency laparotomy.

The purpose of the trial is to find out if the treatments for anaemia will help improve your recovery and quality of life after the surgery that you have had. 

We are looking at two types of treatments that can increase your blood count.  

1.      A single dose of Iron, which is given as an infusion into your vein 

2.     A single dose of an ESA (Darbepoetin), which is given as an injection under your skin.  

Some patients in this study will only receive a single dose of iron, some will receive a single dose of iron plus a single dose of darbepoetin, and some will not receive either of these options (i.e. normal hospital care). All patients, regardless of whether or not they have received iron and/or darbepoetin, will receive the normal hospital care for patients with anaemia after an operation. This normal hospital care is guided by national guidelines and includes clinical observation and possible blood transfusion if required.

We will compare the two treatments for anaemia with normal hospital care to find out if the treatments help you to recover quicker and go home earlier after your surgery. We will measure your recovery by using some simple questionnaires we will send to you after you leave hospital.

If we find that these treatments improve recovery and quality-of-life, then we will be able to recommend that other patients receive them in the future to help them recover from emergency surgeries. 

You have been invited to take part in this study because you have had emergency hip or abdominal surgery and you are aged 60 years or over. Your blood count is lower than normal (anaemia) and the treatments that we are studying might help you to recover. 

We are asking 2400 patients who have had an emergency surgery to take part in this research. 

It is up to you whether or not you take part in the trial.  We will talk to you about the trial and answer any questions you might have. If you agree to take part, we will ask you to sign a consent form. If you decide not to take part, you will continue to receive the usual care that your hospital provides.  

If you decide to take part, we will ask you to sign a consent form. After this, we will either take ablood sample or, if possible, use an existing blood sample. If we need to take a blood sample at this point, we will take approximately 3-5 teaspoons of blood by a qualified medical professional. After this, we will randomly allocate you to one of the three treatment options.

Treatment 1: Normal hospital care and Iron infusion givne through a drip into your vein

Treatment 2: Normal hospital care and Iron infusion given through a drip into your vein, and an injection of darbepoetin.

Treatment 3: Normal hospital care (no extra anaemia treatments)

We will give you the treatment for anaemia as soon as possible if you are allocated to either treatment 1 or 2. If allocated to treatment 1 or 2 then your blood pressure and pulse will be monitored before, during and after the administration of the treatment. We will also ask that you complete a short health-related questionnaire.

We would like to contact you after 30 days and 120 days to find out how you are recovering and whether you have had to go back to hospital during this time. We will also ask you to answer the health-related questionnaire again. This can be done online using a link that we will send you by email or, alternatively, by telephone or by post. We may send you reminders to complete the questions if you do not complete them straight away to ensure we are able to collect data at the right time for the study. With your permission, we will inform your GP, and your elected first point of contact about your participation in this study.

You will be sent a £15 shopping voucher when you are sent the 120-day questionnaire. This is to say thank you for your time, expertise and involvement. We cannot offer any other payment for taking part.

Taking part in the study may or may not directly benefit you, but the information we collect from this study may help us to treat people with anaemia after emergency surgery in the future.

There is also a wider benefit to healthcare as a whole from taking part. If the research demonstrates that the iron or iron + ESA treatments are more effective than normal hospital care, then hospitals may begin offering these treatments to improve patient outcomes. Equally, if the research demonstrates that normal hospital care is as effective as any of the additional treatments, then the NHS may be able to save money, and put less treatment burden on patients, by not offering additional treatments for anaemia.

The treatments that we are using are given to many other patients with different medical conditions in hospitals in the UK. We will monitor your safety during and after the administration of the anaemia treatments and we will be looking at your medical notes to check for any other problems that might be associated with the treatments.

As with all injections or Intravenous (IV) administrations (a drip into your arm), you may experience some short-term minor discomfort at the site where the injection or IV is given.

Intravenous (IV) iron has been associated with some side effects, most of which are very mild. The most common side-effects are:

 - A strange taste for a short time.

- Low blood pressure, which can be treated.

- A raised temperature and shivering.

- Rashes and muscle aches.

Severe reactions to intravenous iron are very unusual.

ESA (Darbepoetin) has been associated with some side effects, most ofwhich are very mild. The most common side-effects are:

- Mild allergic reactions.

- Rashes and swelling.

- Raised blood pressure.

Severe reactions to ESA (darbepoetin) are very unusual.

There is a small risk of blood clots associated with ESA. These may be more common in people with very impaired kidneys or with cancers. This risk is associated with repeated injections of darbepoetinover a longer time. In this study only one injection will be given. The research team in the hospital will check if your medical records for any known health conditions that put you at a high risk of developing a blood clot. If this is the case, then we will not include you in the study. If you have any concerns at all, you can discuss these during the consent process with the research team.

If you have had an infection after your surgery, we will wait until the doctors who are looking after you are happy that you are better before starting you in the study.

To read the Patient Information Leaflets (PIL’s) for these medicines, please request a copy from yourlocal research team or access electronic versions from these links:

Iron Patient Information Leaflet 

ESA (Darbepoetin) Patient Information Leaflet 

If you have concerns or questions about any aspect of this trial, you should ask to speak to the local researchers. Their contact details can be found at the end of the Patient information sheet they handed out to you.  

If any questions remain you can contact the trial coordinating centre,   

Tel: 07974 061 627, Email: POP-I@nottingham.ac.uk. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure via your local Patient Advisory and Liaison Service (PALS). 

In the event that something does go wrong, and you are harmed during the trial, there are no special compensation arrangements. If you are harmed and this is due to someone’s negligence, then you have grounds for a legal action for compensation, but you may have to pay your legal costs. The normal NHS complaints mechanism will still be available to you. 

You are free to withdraw at any time, without giving any reason, and without your legal rights being affected. If you withdraw, the information collected will not be erased and may still be used in the trial analysis. 

Researchers at the Nottingham Clinical Trials Unit (part of the University of Nottingham) will need to use information from you, your medical records, and the local research team for this project.

This information will include your initials, name, contact number and your NHS number (if you are in England or Wales), CHI number (if you are in Scotland), or H&C number (if you are in Northern Ireland). The researchers will use this information to do the research or to check your records to make sure that the research is being done properly. Your contact information will be used by the research team to contact you (via post, email or telephone) to complete study questionnaires, to receive reminders to complete questionnaires, and to share the findings from the study should you wish to receive them. If it is not possible to contact you to complete study questionnaires then we may contact another person who has close contact with you, for example a home carer or staff at a nursing home.

People who do not need to know your identity will not be able to see your name or contact details, your data will have a code number instead.

The researchers may also use information held by your GP, NHS Digital and other central UK NHS bodies to help contact you or provide information about your health status.

All information about you will be kept safe and secure. Once the study has finished, the data will be kept so the results can be checked and you can be told what happened in the study (unless you tell us you do not want to know). Reports will be written in a way so that no-one can work out that you took part in the study.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.   

If you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records. If you do not want this to happen, tell us and we will stop. 

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

After 7 years your data collected during the study will be disposed of securely. If you give us your permission, we may keep your contact details so we can get in touch if there is any relevant future research to do with your condition that you may be interested in taking part in. You will also have the option to take part in future research using your data saved from this study.  If you do not wish for your contact details to be kept for a copy of the study results to be sent to you or to be contacted about future research, these will also be disposed of securely at the end of the study.  

If you provide a mobile telephone number to receive study information, then your name and telephone number will be held by Esendex (text messaging provider) and their subprocessors and will be used to contact you by text message. This information will be deleted by Esendex at the end of the study or after two years (whichever occurs first). 

You can find out more about how we use your information: 

• at www.hra.nhs.uk/information-about-patients/ and www.hra.nhs.uk/patientdataandresearch 

·       https://www.nottingham.ac.uk/utilities/privacy/privacy-information-for-research-participants.aspx 

• at http://www.nctu.ac.uk/data-protection/data-protection.aspx 
• by asking one of the research team 
• by sending an email to POP-I@nottingham.ac.uk 

by calling the Nottingham Clinical Trials Unit on (0115) 823 1600

Sometimes we get new information about your treatment during the study. If this happens your research doctor will tell you about this new information and discuss whether you should continue in the study. If you decide not to carry on, your research doctor will make arrangements for your care to continue as normal.  If you decide to continue in the study they may ask you to sign a new Informed Consent Form. 

The blood sample that we take for this study will be analysed at the local hospital laboratory and the results of the blood tests will be recorded by the research team. The sample will then be destroyed and no further tests will be performed on the blood sample. The results will be shared with the clinical team and the research team running the study. 

When the study ends, your healthcare will continue as normal. If you withdraw from the study, we will need to keep and use the data collected up to your withdrawal. At the end of the study the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will send you a newsletter with a summary of the study findings, unless you ask us not to. 

You will be sent a £15 shopping voucher when you are sent the 120-day questionnaire. This is to say thank you for your time, expertise and involvement. We cannot offer any other payment for taking part.  

Participants who are randomly assigned to receive a treatment will only receive treatment drugs once, at the start of the study. There will be no continued provision of the treatment drugs after the study has ended.