PREVENTT (Preoperative intravenous iron to treat anaemia in major surgery)

•• Design: PREVENTT is a double blind phase III randomised controlled trial. •• Setting: The trial is pragmatic and aims to incorporate the intervention into current normal standard of patient care. Pilot studies confirm the protocol can be performed in existing preoperative surgical pathways; hospital outpatients and surgical preassessment clinics. •• Target population: Patients who are anaemic (Hb of 90-120g/L in women and 90-13-g/L in men) a minimum of 10 and maximum 42 days before undergoing elective major surgery. •• Health technologies assessed: The role of Ferric Carboxymaltose given to patients who are anaemic before they undergo major elective surgery. •• Measurement of costs and outcomes: Surgeons and trial nurses will be blinded to the intervention received by the patient. •Primary outcome is the proportion of patients receiving a blood transfusion in the period from randomisation until thirty days after elective surgery. •Secondary outcomes include: Post-operative complications assessed by the Post Operative Morbidity Survey (POMS) - a validated scoring system used in several NIHR trails; Length of hospital stay; The effect of anaemia on patient quality of life assessed by the Multidimensional Fatigue Inventory (MFI) - a 20-item measure of fatigue - and European Quality of Life-5 Dimensions (EQ-5D); Change in haemoglobin levels from randomisation to operation; total number of units cross matched; total number of packed red cells and any blood products transfused; Safety data will be collected on any reaction or side effect from trial therapy or transfusion reaction; Mortality during follow up. We will also estimate the cost effectiveness of the intervention from the perspective of the NHS using a lifetime horizon. Costs will include length of hospital stay, drug costs, transfusion costs and costs of treating complications following surgery, utilisation of critical care and ward beds. Outcomes in the cost effectiveness analysis will be measured in terms of the primary and secondary outcome measures and QALYs. •• Sample size: Transfusion rates in anaemic patients in pilot studies and the literature described were approximately 40% in all patients undergoing major surgery. Assuming that 40% of patients not receiving intravenous iron undergo transfusion within 30 days a sample size of 500 would give 90% power to detect a 35% relative reduction in the need for transfusion, i.e. to 26% in patients receiving intravenous iron, using a 5% significance level. The sample size allows for losses of up to 5% although these are expected to be minimal for the primary outcome in this patient population. •• Project timetables including recruitment rate: Mths 0 to 6: Initial phase (hiring/training staff, preparation of protocol & study docs) Mths 7-11. Trial set-up phase (ethics, regulatory and R&D approvals, database and randomisation set-up, site set-up) Mths 13 to 72: Recruitment. It is estimated that 300 new patients will undergo planned major surgery p.a. at each centre, half will have anaemia at presentation. Patients will be identified by review of the blood results from either multidisciplinary meetings or preassessment clinics (both methods were successful in pilot studies). We anticipate a minimum 10% consent rate so 15 patients per centre p.a. Approximately 35-40 UK centres will take part. The aim is to complete recruitment within 5.0 yrs (i.e. an average target of 10 pts/per centre/p.a. assuming 5 initial centres, 10 centres open by mth 6 & 20 centres open by mth 12). Mths 73-79: follow-up of pts (three month assessment). Mths 80-86: final data cleaning/validation, Mths 80-86 principal analysis & manuscript preparation, economic health analysis. Total project duration 7.0 yrs.