NCT02057471

Intravenous Iron: Measuring Response in Anemic Surgical Patients

An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nottingham University Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

20 Patients will be recruited with confirmed colorectal adenocarcinoma and anemia who are planned to undergo surgery. All patients will be treated with a single dose of 1g intravenous ferric carboxymaltose (FERINJECT). It is hypothesized that intravenous iron supplementation is efficacious at raising haemoglobin levels and reduced blood transfusion requirements.

Detailed description

Patients who are anemic at the time of operation have been shown to have an increased frequency of complications including wound infection and longer post-operative admissions. Similarly, patients who are anemic at the time of their cancer operation are more likely to require a blood transfusion which may increase the risk of recurrence of the cancer. At present, oral iron is often used to treat anemia preoperatively in an attempt to minimize the risk above. This drug is often poorly tolerated due to the side effect profile. Blood transfusions can also be administered but expose the patient to other risks including infection and transfusion associated reactions. In order to overcome these issues, intravenous iron preparations have been developed and have improved in safety. This is open label clinical trial, which looks to investigate the efficacy of intravenous iron is in the treatment of preoperative anemia in colorectal patients. The outcomes reviewed will include the amount and frequency of blood transfusions received, changes in patient blood profiles operative complications and hospital length of stay. The role of hepcidin as a biomarker of treatment response will also be assessed. All data will be confidentially recorded on a Case Report Form, as will drug reactions and side effects.

Conditions

• Colorectal Neoplasm
• Anemia

Interventions

Type	Name	Description
DRUG	Intravenous ferric carboxymaltose	1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2012-03-01
• First posted: 2014-02-07
• Last updated: 2014-02-07

Locations

1 site across 1 country: United Kingdom