Rapid Administration of iron Polymaltose whilst In the operating Department for patients with iron deficiency The RAPID Study

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The RAPID Study – Lay Description Rapid Administration of iron Polymaltose whilst In the operating Department Background, aims & objectives We aim to show that giving intravenous iron polymaltose over 15 minutes to patients who are under general anaesthesia is safe and not associated with a significant incidence of low blood pressure or other adverse effects. Anaemia and iron deficiency are very common in surgical patients, a recent audit at KEMH showed an incidence of around 18%. In patients undergoing surgery it has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patient often suffer from decreased energy, fatigue and poor ability to concentrate, all of which will affect their quality of life. Iron polymaltose is an intravenous iron medication commonly used to correct anaemia and iron deficiency. It has been used in Australia for over 40 years, has a very good safety record and about 4-500 women a year receive iron polymaltose at KEMH currently. It is usually administered as a slow infusion over 1.5 – 2.5 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. Low blood pressure can occur less commonly. Serious adverse events such as anaphylaxis are extremely rare and are not related to the speed at which iron polymaltose is given. Oral iron tablets are not effective in many patients for a number of reasons. It would labour intensive, expensive and inconvenient to bring all these patients back to a ward for a 1-2 hour infusion of iron polymaltose after surgery. Many other intravenous iron preparations, with similar pharmacological properties, have been shown to be safe when given over similar short periods of time and we believe this will be the case with iron polymaltose too. Some anaesthetists (in Australia and NZ) have already administered iron polymaltose in this manner with no anecdotal reports of any problems, however we believe it warrants formal evaluation. Study Population 100 Adult patients with anaemia or iron deficiency, undergoing general anaesthesia. Study Design and Methods Prospective, interventional study. Patients will act as their own controls. Temporary low blood pressure is quite common after the initial injection of anaesthetic medications used to start a patients general anaesthetic. We think that the proportion of patients with low blood pressure following iron polymaltose administration will be significantly less than this. We estimate we would need 83 patients, but because we anticipate some dropouts, or incomplete data we aim to recruit 100 (across both sites). Because anaemia is so common we think we should be able to get this many patients in 12 months or less. Outcomes Primary outcome will be the incidence of significant low blood pressure following the administration of iron polymaltose (definition = systolic BP less than 80). Secondary outcomes, will be the incidence of all adverse effects as ascertained by questionnaire 2 hours and 2 days after surgery.

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