INtravenous Iron to Treat Anaemia following CriTical care (INTACT): A protocol for a feasibility randomised controlled trial
Shah A., Marian I., Dutton SJ., Barber VS., Griffith DM., McKechnie SR., Chapman G., Robbins PA., Young D., Walsh TS., Stanworth SJ.
<jats:sec><jats:title>Background</jats:title><jats:p> Anaemia is common in patients who survive critical illness and is associated with high levels of fatigue and poor quality of life. In non-critically ill patients, treating anaemia with intravenous iron has resulted in meaningful improvements in quality of life, but uncertainties regarding the benefits, risks, timing and optimal route of iron therapy in survivors of critical illness remain. </jats:p></jats:sec><jats:sec><jats:title>Methods / Design</jats:title><jats:p> INtravenous Iron to Treat Anaemia following CriTical care (INTACT) is an open-label, feasibility, parallel group, randomised controlled trial with 1:1 randomisation to either intravenous iron (1000 mg ferric carboxymaltose) or usual medical care. The primary objective is to assess the feasibility of a future, multicentre randomised controlled trial. Participants will be followed up for up to 90 days post-randomisation. The primary outcome measures, which will be used to determine feasibility, are recruitment and randomisation rates, protocol adherence and completeness of follow-up. Secondary outcome measures include collecting clinical, laboratory, health-related quality of life and safety data to inform the power calculations of a future definitive trial. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Improving recovery from critical illness is a recognised research priority. Whether or not correcting anaemia, with intravenous iron, improves health-related quality of life and recovery requires further investigation. If so, it has the potential to become a rapidly translatable intervention. Prior to embarking on a phase III multicentre trial, a carefully designed and implemented feasibility trial is essential. </jats:p></jats:sec>