RecruitingPhase IIIInterventional

INTACT2: Improving ICU outcomes by treating anaemia

After a stay in intensive care (ICU), many people have anaemia, which can make them feel weak and tired. This study, called INTACT2, is looking for better ways to help these patients recover. We're testing if two treatments — iron given through a drip and a hormone injection — can improve their health and quality of life once they leave ICU. Both treatments are already used in the NHS and are generally considered safe. Half of the participants will receive these treatments, while the other half will get dummy treatments (placebos), allowing us to compare the results carefully. We hope to find out if treating anaemia can help people get back to their normal lives more quickly and feel better overall.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Edinburgh & NHS Lothian ACCORD

Enrolment target

508

Start

06 Oct 2025

Estimated completion

30 Nov 2026

Anaemic survivors of critical illness defined as patients who have received Intensive Care Society Level 2 or 3 care who are ready for discharge from Critical Care (i.e. an ICU or HDU in the UK) who are have mild or moderate anaemia (plasma haemoglobin ≤100 g/L prior to ICU/HDU discharge)

What is this study about?

When people are very unwell and need intensive care, their bodies often struggle to make enough healthy red blood cells. This leads to something called anaemia, where you don't have enough haemoglobin – a part of your blood that carries oxygen. Anaemia can make you feel extremely tired, weak, and can slow down your recovery, meaning you might stay in hospital longer or find it harder to cope when you go home. Doctors and patient groups have highlighted that we need to find better ways to help people get over this.

This study is investigating if giving people two specific treatments can help them recover better. One treatment is iron, which is given directly into a vein through a drip. The other is a man-made version of a natural body hormone, which is given as an injection under the skin. Both of these treatments are currently used in the NHS for other conditions and are considered safe. Our goal is to see if treating anaemia with these methods can genuinely improve how people feel and their overall health and quality of life after their intensive care stay.

We will be carefully measuring how participants feel and their ability to do everyday things, like walking, dressing, and enjoying their lives, using questionnaires. We'll also look at how much time they spend at home and their health at different points after joining the study. By collecting this information, we hope to understand if these treatments make a real difference to recovery and help people get back to feeling like themselves again. This research is important because it could lead to better care for many people recovering from serious illness.

Key takeaways

Anaemia is common after intensive care and can make recovery harder.
This study tests if iron and a hormone injection can improve recovery and quality of life.
Half of participants will receive active treatments, and half will receive dummy treatments.
The treatments are already used in the NHS and are generally safe.
Your participation could help improve future care for other critically ill patients.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults aged 16 or over who have been in intensive care (ICU or HDU) for at least 24 hours due to a serious illness. To be considered, you must be well enough to leave intensive care and have mild or moderate anaemia (a blood test showing your haemoglobin is 100 g/L or less) before you are discharged.

There are several reasons why someone might not be able to join the study. For example, if you have an uncontrolled infection, certain types of cancer, severe liver disease, or a condition called haemochromatosis (where you have too much iron). You also can't take part if you're pregnant, have recently received iron or the study hormone, or have certain other medical conditions like severe traumatic brain injury, specific heart problems, or a known allergy to the study medications. We also can't include you if you are receiving end-of-life care.

Before you join, the study team will check your medical records carefully to make sure it's safe for you to participate and that you meet all the necessary requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or over?
Have you been in intensive care (ICU or HDU) for at least 24 hours?
Are you ready to be discharged from intensive care?
Do you have mild or moderate anaemia (low blood count before discharge)?
Have you had any of the listed conditions that might stop you from joining, such as ongoing serious infection or certain cancers?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups: one receiving the iron infusion and hormone injection, and the other receiving inactive dummy treatments (placebos) that look identical. The iron infusion and hormone injection (or placebos) will be given while you are still in the hospital. The study team will monitor you closely during and after these treatments.

You will be asked to complete questionnaires about your physical health and quality of life at different times after leaving the hospital. These can be done by phone, in person, by post, or online, whichever is easiest for you. We will also collect blood samples to help us understand how the treatments work. We'll track how much time you spend at home and your overall health at 30 and 90 days after you join the study. We will also look at your routine NHS medical information. The study is expected to run from August 2024 to November 2027.

Potential risks and benefits

Taking part in this study may not directly benefit you, but it could help improve future treatments for other patients recovering from intensive care. Early research hints that treating anaemia might help patients go home sooner and reduce their chances of returning to hospital. The treatments used in this study are already common in the NHS and are generally safe. The study team will carefully check your medical records to ensure you don't have existing conditions that could put you at risk. As with any injection or drip, you might experience slight discomfort or bruising where the needle goes in. The iron infusion can cause mild side effects like nausea, a strange taste, headache, or flushing, though serious allergic reactions are very rare. The hormone injection can cause rashes, swelling, or discomfort at the injection site, and rarely, a small risk of blood clots, though this has not been seen in previous studies with ICU patients. You are always free to withdraw from the study at any time without it affecting your usual medical care.

Locations (1)

The Royal Infirmary of Edinburgh
Approximate
Edinburgh, Scotland

Common questions

What is anaemia?

Anaemia means you have low levels of healthy red blood cells, which carry oxygen around your body. It can make you feel very tired and weak.

What are the treatments being tested?

We're testing an iron treatment given through a drip, and an injection of a hormone that helps your body make more red blood cells.

Will I know if I'm getting the real treatment or a dummy one?

No, you won't. This is called 'double-blind' so that neither you nor the study team knows, ensuring fair results.

How long will I be involved in the study?

The main part of the study involves assessments and checking your health at 30 and 90 days after you join, along with the initial treatment.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR).

How to find out more

Fiach O’Mahony

INTACT2.trial@ed.ac.uk +44 (0)131 242 9361 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.