Intravenous Iron: Measuring Response in Anemic Surgical Patients

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057471
• Other study ID #: 09GS002
• Secondary ID: 2009-011382-80
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2014
• Last updated: February 5, 2014
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2014
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Drug:
• Intravenous ferric carboxymaltose
1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No