Intravenous Iron: Measuring Response in Anemic Surgical Patients

Phase 4

Completed

• Conditions: Colorectal Neoplasm; Anemia
• Interventions: Drug: Intravenous ferric carboxymaltose

• Registration Number: NCT02057471
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief 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.

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-01
• Study Completion: 2012-03
• Status Verified: 2014-02
• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-05
• Last Update Submitted: 2014-02-05
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age > 18 years
• Diagnosed with colonic or rectal adenocarcinoma
• Defined date of operation at least 14 days from recruitment to study
• Confirmed anemia
• Females of child bearing age must agree to use a medically accepted form of contraceptive

Exclusion Criteria

• Patient's who are unable to consent
• Recognized allergy or intolerance of the study drug or excipients
• Patients with previous or current hematological disease that in the investigators' opinion would confound the diagnosis of anemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intravenous Ferric Carboxymaltose	Intravenous ferric carboxymaltose	All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

Primary Outcome Measures

Name	Time	Method
Number of patients transfused allogenic red blood cells	Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks	To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase
Hemoglobin levels	Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks	To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients

Secondary Outcome Measures

Name	Time	Method
Transferrin saturation levels	Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks	To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy
Ferritin levels	Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks	To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy
Hepcidin levels	Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks	To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy
Erythropoietin levels	Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks	To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy
C Reactive Protein levels	Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks	To monitor changes in C Reactive Protein levels over the course of the study, and review if this can predict response to intravenous iron therapy, or is associated with changes in hepcidin

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, Nottinghamshire, United Kingdom