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Trial record 86 of 380 for:    FERRIC CATION

Intravenous Iron: Measuring Response in Anemic Surgical Patients

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

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057471


Locations
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United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
Investigators
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Study Chair: Austin G Acheson, MD FRCS Nottingham University Hospitals NHS Trust

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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02057471     History of Changes
Other Study ID Numbers: 09GS002
2009-011382-80 ( EudraCT Number )
First Posted: February 7, 2014    Key Record Dates
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:
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Ferric Compounds
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
Hematinics