Clinical trial NCT02057471: Intravenous Iron: Measuring Response in Anemic Surgical Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Neoplasm
Anemia
Keywords: Adenocarcinoma
Anemia
Blood Transfusion
Colorectal surgery
Preoperative care
Perioperative care
Postoperative care
Iron
Hematinics
Hepcidin
Quality of life
Postoperative complications
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients transfused allogenic red blood cells
timeFrame: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks
measure: Hemoglobin levels
timeFrame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Secondary outcomes:
measure: Hepcidin levels
timeFrame: Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks
measure: Erythropoietin levels
timeFrame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
measure: Transferrin saturation levels
timeFrame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
measure: Ferritin levels
timeFrame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
measure: C Reactive Protein levels
timeFrame: Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks
Other outcomes:
measure: Number of adverse events associated with intravenous iron infusion
timeFrame: Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Austin G Acheson, MD FRCS
role: STUDY_CHAIR
References: