Intravenous Iron: measuring response in anaemic surgical patients

• Research type

  Research Study

• Full title

  Intravenous Iron: biomarkers and treatment strategies in anaemic Colorectal cancer patients.

• IRAS ID

  14755

• Sponsor organisation

  Nottingham University Hospital

• Eudract number

  2009-011382-80

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Colorectal cancer is the third commonest cancer in the UK and is associated with anaemia in up to 60% of cases. In patients undergoing surgical resection of their tumour, preoperative anaemia has been associated with adverse perioperative outcomes. Surgical teams endeavour to correct preoperative anaemia using a number of existing treatment strategies. Treatment with oral iron, iron supplements and blood transfusion have all been met with mixed results but newer intravenous iron preparations have recently been introduced to the market with promising results for treating perioperative anaemia in small surgical cohorts.However, even in these studies intravenous iron has not been effective in all patients. This raises concern over the correct identification of the type of anaemia present in surgical patients. Although it is common for gastrointestinal cancer patients to present with iron deficiency anaemia (IDA), it is recognised that a proportion of these patients will also suffer from anaemia of chronic disease (ACD). Furthermore a separate proportion of surgical patients will have coexisting pathology such as gastric atrophy and erosion which may exacerbate IDA and impair absorption of oral medication.The identification of specific biomarkers that indicate a patient??s response to iron therapy is key to improving the treatment of anaemia. One such biomarker is the liver protein, hepcidin, which is responsible for controlling iron absorption from the GI tract and the release of stored iron. Increased hepcidin expression effectively prevents absorption and release of iron and correlates with progession stages in colorectal cancer. This study will measure the efficacy of intravenous iron as a treatment for anaemia in surgical patients, and at the same time provide valuable mechanistic data through analysis of iron biochemistry, including hepcidin. This will identify potential iron biomarkers and determine the suitability of intravenous iron as a standard preoperative treatment for anaemia.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/67

• Date of REC Opinion

  22 Jun 2009

• REC opinion

  Further Information Favourable Opinion