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Completed

NCT Number: NCT02057471

Intravenous Iron: Measuring Response in Anemic Surgical Patients

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.

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Key information

Conditions

Colorectal Neoplasm Adenocarcinoma Anemia Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous ferric carboxymaltose

Drug

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

Other names: FERINJECT

Primary outcomes

  1. Number of patients transfused allogenic red blood cells

    Time frame: 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

  2. Hemoglobin levels

    Time frame: 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 outcomes

  1. Hepcidin levels

    Time frame: 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

  2. Erythropoietin levels

    Time frame: 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

  3. Transferrin saturation levels

    Time frame: 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

  4. Ferritin levels

    Time frame: 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

  5. C Reactive Protein levels

    Time frame: 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

Other outcomes

  1. Number of adverse events associated with intravenous iron infusion

    Time frame: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks

    To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 7, 2014
Registry last updated
Feb 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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