ITACS Trial

• Research type

  Research Study

• Full title

  IV iron for Treatment of Anaemia before Cardiac Surgery

• IRAS ID

  217991

• Contact name

  Toby Richards

• Contact email

  toby.richards@ucl.ac.uk

• Sponsor organisation

  Alfred Health

• Eudract number

  2016-004439-19

• Clinicaltrials.gov Identifier

  NCT02632760

• Duration of Study in the UK

  4 years, 0 months, 31 days

• Research summary

  To determine whether a single dose of IV (intravenous) iron (iron isomaltoside 1000) given to anaemic patients before elective cardiac surgery improves outcome after surgery and is cost effective. To be able to also identify biomarkers that predict iron responsiveness in the preoperative setting and better understand mechanisms of functional iron deficiency in surgical patients with heart disease.

  This is a large, multicentre, randomised double blind controlled phase 4 trial that will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  17/LO/0657

• Date of REC Opinion

  1 Jun 2017

• REC opinion

  Further Information Favourable Opinion