IV iron for Treatment of Anaemia before Cardiac Surgery - ITACS Trial

Alfred Health0 sites1,000 target enrollmentApril 6, 2017

Overview

No summary available.

Registry

who.int

Start Date

April 6, 2017

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Adult patients (\=18 years)
•2\) Patients with anaemia (males (Hb) \<130g/L, females \<120g/L) undergoing elective cardiac surgery, and able to receive trial drug 1\-10 weeks prior to planned surgery
•3\) Negative pregnancy test for women of childbearing age (within last 7 days), and agree to use effective form of contraception (e.g. hormonal contraception, intrauterine device/hormone\-release system, bilateral tubal occlusion, vasectomised partner, sexual abstinence) until 6 weeks post treatment
•4\) Able to provide written informed consent
•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 200

•1\) Pregnant, planning pregnancy, lactating or breast\-feeding
•2\) Known hypersensitivity to study drug (Iron isomaltoside 1,000 or equivalent) or its excipients
•3\) Previously documented TSAT \>50%
•4\) Known or suspected haemoglobinopathy/thalassaemia
•5\) Known and untreated cause for anaemia such as B12 deficiency.
•6\) Renal dialysis (current or planned within the next 12 months)
•7\) Erythropoietin or IV iron in the previous 4 weeks
•8\) Ongoing bacteraemia (as confirmed in accordance with routine investigations for septic work up such as FBC, blood cultures, urine and stool MCS)
•9\) Temperature \>37\.5°C
•10\) Decompensated liver cirrhosis and hepatitis