Anaemia (specifically related to surgical pathology)
Conditions
Interventions
Trade Name: Ferinject
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Ferric Carboxymaltose
CAS Number: 9007-72-1
Concent
Sponsors
Nottingham University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Age >18yrs Diagnosis of Colorectal Cancer and a defined surgical operation date Biochemically detectable anaemia. Women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study; (e.g. intra-uterine device (IUD) or a double-barrier method of oral contraception with condom) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: Patients with a recognised allergy to intravenous iron, or related products. A concurrent medical condition(s) that,in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients. Any of the following groups: Children; those unable to consent for themselves; pregnant females; prisoners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the use of intravenous iron provide a safe and effective treatment for anaemia in surgical patients and does the use of intravenous iron lead to a reduction in allogenic blood transfusion?;Secondary Objective: Can the expression level of the liver protein, hepcidin, be used to more accurately categorise anaemia in surgical patients? Furthermore, can these levels predict response to treatment with intravenous iron?;Primary end point(s): Change in the immediate preoperative haemoglobin concentration. | — |
Countries
United Kingdom
Outcome results
None listed