INtravenous iron and eryThropoietin to treat Anaemia following CriTical care 2: a multi-centre, randomised, parallel group, double blind, placebo controlled, clinical efficacy trial (INTACT2)

Research summary

Anaemia (low blood count) is common in patients who survive ICU. It makes them feel weak and tired. This can lead to longer hospital stays, difficulty in coping at home after leaving hospital and poor quality of life. Expert committees and patient groups have called for research to find the best way to treat anaemia in ICU survivors. We want to see if treating anaemia improves patients’ health after they leave ICU. Our research will test if two treatments – iron (infused into the veins) and a man-made version of a hormone normally produced by the body (recombinant EPO, given as an injection under the skin) – can successfully treat anaemia and improve physical aspects of health-related quality of life. These treatments are safe and are already used in the NHS to treat anaemia in heart and kidney disease. We will split 508 people into two groups at random (‘by chance’): half will get iron and rHuEPO and half will get identical looking placebos (dummy drugs). These dummy drugs will contain salt water but no “active” drugs. We will then measure physical health using a reliable questionnaire that has been used in many ICU studies. It will give us important information about ICU survivors’ quality of life including ability to carry out essential activities of daily living (bathing, dressing, eating, shopping), and how much they are able to walk, exercise, return to work and enjoy life in general. We will also collect blood samples to understand how the treatments work, information about how much time patients spend at home after leaving hospital, and their overall health at 30 and 90 days after entering the study. We will also collect routine NHS electronic clinical information to help us work out how much the treatments cost the NHS and how much they save. We have an experienced team running the study. They include doctors, scientists, former patients, health economists and statisticians. Together they will make sure the study runs smoothly and finishes on time.

Principal Investigator

Dr Stuart McKechnie

Contact us

Email: ICUResearch@ouh.nhs.uk

IRAS number

1011145