A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery - Preoperative intravenous iron to treat anaemia in major surgery

niversity College London0 个研究点目标入组 500 人开始时间: 2012年9月7日最近更新: 2020年6月2日

适应症

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•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

•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.

发起方

niversity College London