Intravenous Iron: Measuring Response in Anemic Surgical Patients

NCT ID: NCT02057471

Last Updated: 2014-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Colorectal Neoplasm; Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Ferric Carboxymaltose

All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment

Group Type: EXPERIMENTAL

Intravenous ferric carboxymaltose

Intervention Type: DRUG

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

Interventions

Intravenous ferric carboxymaltose

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

Intervention Type: DRUG

Other Intervention Names

FERINJECT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Austin G Acheson, MD FRCS

Role: STUDY_CHAIR

Nottingham University Hospitals NHS Trust

Locations

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2009-011382-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

09GS002

Identifier Type: -

Identifier Source: org_study_id