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Trial rules out intravenous iron therapy as preoperative treatment for patients with anaemia before major surgery

 

A landmark trial funded and supported by NIHR has found that a common global procedure of giving anaemic patients intravenous iron therapy before major surgery gives little benefit.

Researchers led by a team at University College London (UCL) found that the treatment - which is routinely administered worldwide - did not reduce the need for blood transfusions or the risk of death among patients with anaemia undergoing major abdominal surgery.

Now results of the PREVENTT study, which is the first randomised controlled trial of its kind to evaluate the therapy, are published in the Lancet.

Preoperative anaemia affects around 30-60% of all patients undergoing major elective surgery, with hundreds of thousands of people affected globally each year.The condition is associated with an increased need for blood transfusion, postoperative complications and longer stays in hospital after major surgery.

Over the last decade hospitals around the world have given intravenous iron to these patients in advance of their operations, based on global recommendations. But this procedure has never been tested in a large trial.

The study was carried out in 46 UK centres, where 487 patients were randomised, with half receiving intravenous iron and the others given a placebo of saline solution, 10-42 days before surgery.

Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (13 patients dropped out in total). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group. Researchers concluded  that preoperative intravenous iron was “non-superior” to placebo.

Chief Investigator Toby Richards, Professor of Surgery at UCL and the University of Western Australia (UWA), said: “Each year, hundreds of thousands of people around the world with preoperative anaemia are receiving intravenous iron before undergoing surgery. But this trial, the largest of its kind, shows that this treatment doesn’t reduce mortality or the need for blood transfusions.

"At a time when the physical and emotional demands on pre-operative patients are already considerable, being able to reduce the number of treatments they have to go through will hopefully make their experience less stressful." 

Professor Hywel Williams, Director of the NIHR’s Health Technology Assessment (HTA) Programme, which funded the study, said: “This study contains important evidence that could save considerable time and cost and significantly change medical practice in the UK and beyond.

"It’s reassuring that even in this era of COVID-19 studies such as this can continue, and as it has with COVID-19, UK research once again contributes to the sum total of scientific knowledge"

The study also involved researchers from London School of Hygiene & Tropical Medicine and was supported by the NIHR’s Clinical Research Network (CRN).

Read more about the study on the NIHR Funding and Awards website.