Intravenous Iron: Measuring Response in Anemic Surgical Patients

• ClinicalTrials.gov Identifier: NCT02057471
• Recruitment Status: Completed
• First Posted: February 7, 2014
• Last Update Posted: February 7, 2014
• Sponsor: Nottingham University Hospitals NHS Trust
• Information provided by (Responsible Party): Nottingham University Hospitals NHS Trust

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Neoplasm; Anemia	Drug: Intravenous ferric carboxymaltose	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Study of Intravenous Iron (FERINJECT) in Colorectal Adenocarcinoma Related Anaemia to Identify Potential Biomarkers of Responsiveness to Intravenous Iron
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

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 Name: FERINJECT

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom, NG7 2UH

Sponsors and Collaborators

Nottingham University Hospitals NHS Trust

Investigators

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

More Information

• Responsible Party: Nottingham University Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT02057471
• Other Study ID Numbers: 09GS002; 2009-011382-80 ( EudraCT Number )
• First Posted: February 7, 2014
• Last Update Posted: February 7, 2014
• Last Verified: February 2014

Keywords provided by Nottingham University Hospitals NHS Trust:

Adenocarcinoma; Anemia; Blood Transfusion; Colorectal surgery; Preoperative care; Perioperative care; Postoperative care; Iron; Hematinics; Hepcidin; Quality of life; Postoperative complications

Additional relevant MeSH terms:

Colorectal Neoplasms; Anemia; Hematologic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases