An open label study to determin the efficancy of ferric carboxymaltose in preoperative colorectal cancer related anaemia, and to develop biomarkers to predict response to this treatment strategy (IVICA)

1st June 2011

Status: Ended

Specialism: Surgical.

Team: Dr Austin Acheson.

Anaemia is a common finding in patients with pathology in the gastrointestinal tract. The anaemia has multiple aetiology; blood loss from the gastrointestinal tract, malabsorption and chronic inflammation as a result of inflammatory bowel disease. Anaemia causes symptoms of lethargy, dizziness, shortness of breath and chest pain. Oral iron supplementation is routinely used as a first-line treatment. However, side-effects include dyspepsia, constipation and diarrhoea, resulting in poor compliance. Inflammation within the gastrointestinal tract further compounds the poor absorption of oral iron.

Pre-operative anaemia is an independent risk factor for allogeneic blood transfusion. Blood is an expensive and limited resource and carries a risk of infection. Pre-operative anaemia is also linked to increased post-operative morbidity and mortality.

Hepcidin is a peptide produced in the liver that is involved in the control of iron metabolism. Hepcidin production is upregulated as a result of iron loading and inflammation. Hepcidin binds to ferroportin, an iron exporter located on enterocytes, and causes ferroportin to be internalised and degraded. As a result, the iron that is absorbed is not made available to the circulation for erythropoiesis.

We plan to carry out an open label study comparing the use of intravenous ferric carboxymaltose to oral ferrous sulphate for pre-operative anaemia in patients undergoing surgery for colorectal adenocarcinoma. We are also investigating biomarkers (hepcidin) that may stratify a group of patients that show a better response to intravenous iron in order to better tailor management of pre-operative anaemia.

The primary objective is to assess if the use of intravenous ferric carboxymaltose will reduce the requirements for allogeneic blood transfusion in patients with pre-operative anaemia. The secondary objectives are to assess the use of hepcidin as a biomarker to stratify patients to a group more responsive to intravenous iron and to assess any side-effects to intravenous iron.

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dr-austin-acheson Dr Austin Acheson Research Summary Interests Chronic anal fissure Anal sphincter Pharmacology Intravenous iron therapy in IDA Laparoscopic Colorectal Surgery Techniques In vitro models for sphincter pharmacology clinical studies…
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