Anaemia MedDRA version: 19.0 Level: PT Classification code 10022972 Term: Iron deficiency anaemia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Ferinject
Product Name: Ferric Carboxymaltose (Ferinject)
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Ferric carboxymaltose
CAS Number: 0009007-72-1
Concentra
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years of age and signed written informed consent. 2. Patients undergoing elective major open abdominal surgery. a. The Indication for operation may be for benign or malignant disease. b. Major Surgery is defined as an operation of anticipated duration more than one hour. 3. Screening haemoglobin (Hb) greater than or equal to 90 g/L (9.0 g/dL) but below or equal to 120 g/L (12.0 g/dL) in women or 130g/L (13.0g.dL) in men within four weeks of randomisation. 4. Randomisation and administration of study infusion a minimum of 10 days and maximum 42 days before planned operation. 5. Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment. 6. Laboratory data used for determination of eligibility at the baseline visit must not be older than four weeks. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400
Exclusion criteria
Exclusion criteria: 1. Patients undergoing laparoscopic surgery. 2. Body weight under 50kg. 3. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or TSAT >50%. 4. Known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy). 5. Known hypersensitivity to ferric carboxymaltose (Ferinject®) or its excipients. 6. Temperature > 37.5?C or patient on non-prophylactic antibiotics 7. Known chronic liver disease 8. If clinically indicated for the patient to have LFT’s as part of preassessment for surgery and this screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of the normal range. 9. Received erythropoietin or i.v. iron therapy in the previous 12 weeks. 10. Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or planned within the next 12 months). 11. Patients with severe asthma or severe allergy (requiring hospitalisation within the last 12 months). 12. Unfit for elective surgery. 13. Pregnancy or lactation. 14. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion. 15. Patient involvement in another IMP trial within the previous 4 weeks, prior to randomisation. Involvement in another IMP trial, following randomisation, that may impact on the results of the PREVENTT trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if a single dose of intravenous iron given to patients with anaemia prior to major open abdominal surgery, reduces the need for peri-operative blood transfusion (the peri-operative period is defined as from randomisation to the trial until 30 days following operation);Secondary Objective: To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on change in haemoglobin levels. To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on post-operative morbidity, length of hospital stay and mortality. To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on health related quality of life. To evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject®) compared with placebo. To evaluate the tolerability and safety of Ferinject® compared with placebo from randomisation till study termination. To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on: o Complications of the intervention itself. o Complications from blood transfusion or blood products.;Primary end point(s): The co-primary outcomes are: • Risk of blood transfusion or death from randomisation until 30-days following the index operation. • Blood transfusion rate (including repeat transfusions) from randomisation until 30-days following the index operation.;Timepoint(s) of evaluation of this end point: 30-days post operation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in haemoglobin levels; total number of units of blood transfused; post operative morbidity; change in health related quality of life (HRQOL); health economic outcome; safety & related efficacy outcomes.;Timepoint(s) of evaluation of this end point: Change in haemoglobin levels – at operation and 8 weeks and 6 months post operation; Total number of units of blood transfused – at 30 days post operation; Post operative morbidity – at 3 days, 5 days, 7 days and 14 days post operation; Change in HRQOL from baseline to – 10 days post transfusion, 8 weeks and 6 months post operation. | — |
Countries
United Kingdom
Contacts
Public ContactLaura Van Dyck
London School of Hygiene & Tropical Medicine
Outcome results
None listed