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

niversity College London (UK)0 sites487 target enrollmentOctober 9, 2012

Overview

Registry

who.int

Start Date

October 9, 2012

End Date

May 20, 2019

Last Updated

5 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity College London (UK)

•Current inclusion criteria as of 23/04/2015:
•1\. At least 18 years of age and signed written informed consent
•2\. Patients undergoing elective major open abdominal surgery
•2\.1\. The Indication for operation may be for benign or malignant disease
•2\.2 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 130 g/L (13\.0 g/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
•Previous inclusion criteria from 24/01/2014 to 23/04/2015:

•Current exclusion criteria as of 30/09/2016:
•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 degrees 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 pre\-assessment 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