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Intravenous Iron: Measuring Response in Anemic Surgical Patients

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NHS Trust

Status and phase

Completed
Phase 4

Conditions

Anemia
Colorectal Neoplasm

Treatments

Drug: Intravenous ferric carboxymaltose

Study type

Interventional

Funder types

Other

Identifiers

NCT02057471
09GS002
2009-011382-80 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Intravenous Ferric Carboxymaltose
Experimental group
Description:
All recruited patients will be allocated to this treatment. 1 gram of Ferric carboxymaltose (FERINJECT) to be given at recruitment
Treatment:
Drug: Intravenous ferric carboxymaltose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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