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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Colorectal Neoplasm
• Intervention / Treatment: Drug: Intravenous ferric carboxymaltose

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous Ferric Carboxymaltose; All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment	Drug: Intravenous ferric carboxymaltose; 1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study; Other Names: FERINJECT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events associated with intravenous iron infusion	To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit	Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Nottingham University Hospitals NHS Trust
• Investigators: Study Chair: Austin G Acheson, MD FRCS, Nottingham University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 3, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Estimate): February 7, 2014
• Last Update Submitted That Met QC Criteria: February 5, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Adenocarcinoma; Anemia; Blood Transfusion; Colorectal surgery; Preoperative care; Perioperative care; Postoperative care; Iron; Hematinics; Hepcidin; Postoperative complications
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Anemia
• Other Study ID Numbers: 09GS002; 2009-011382-80 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No