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 (PREVENTT)

7th June 2016 - ongoing

Status: In Recruitment

Specialism:

Team: Dr Austin Acheson.

Primary Objective:

To determine if a single dose of intravenous iron (ferric carboxymaltose; 1000mg) given to patients with anaemia prior to major open abdominal surgery reduces the need for peri-operative blood transfusion. For the purpose of this trial the peri-operative period is defined as from randomisation to until 30 days following operation.

Secondary Objectives:

  • 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:

  • Complications of the intervention itself
  • Complications from blood transfusion or blood products
People
Photo Name Bio
dr-austin-acheson Dr Austin Acheson Research Summary Interests Chronic anal fissure Anal sphincter Pharmacology Intravenous iron therapy in IDA Laparoscopic Colorectal Surgery Techniques In vitro models for sphincter pharmacology clinical studies…
Publications
Title
Grants
Title Amount