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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02057471
Other study ID # 09GS002
Secondary ID 2009-011382-80
Status Completed
Phase Phase 4
First received February 3, 2014
Last updated February 5, 2014
Start date September 2009
Est. completion date March 2012

Study information

Verified date February 2014
Source Nottingham University Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham Nottinghamshire

Sponsors (1)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of adverse events associated with intravenous iron infusion To assess the safety and feasibility of the principle of administration of intravenous iron in a single dose, preoperative outpatient visit Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks No
Primary Number of patients transfused allogenic red blood cells To determine if the administration of intravenous iron reduces the number of expected allogenic red blood cell transfusions from recruitment to the perioperative phase Patients will be followed from recruitment to the study until postoperative discharge from hospital, which will be an expected average of 4 weeks No
Primary Hemoglobin levels To determine if intravenous iron significantly increases hemoglobin levels in the preoperative optimization of patients Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks No
Secondary Hepcidin levels To monitor changes in hepcidin in response to treatment and review if this can predict response to intravenous iron therapy Patients will be followed from recruitment to the study until the day after surgery, which will be an expected average of 3 weeks No
Secondary Erythropoietin levels To monitor changes in Erythropoietin in response to treatment and review if this can predict response to intravenous iron therapy Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks No
Secondary Transferrin saturation levels To monitor changes in transferrin saturation levels in response to treatment and review if this can predict response to intravenous iron therapy Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks No
Secondary Ferritin levels To monitor changes in ferritin levels in response to treatment and review if this can predict response to intravenous iron therapy Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks No
Secondary C Reactive Protein levels 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 Patients will be followed from recruitment to the study until 8 weeks post operatively, which will be an expected average of 10 weeks No
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