The RIVIVAL trial has received £2.9m funding from a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership.
Newcastle Hospitals is leading a multi-centre clinical trial to find out if administering iron to patients with a life-threatening vascular condition can help recovery.
Chronic limb threatening ischaemia (CLTI) is a severe form of peripheral artery disease, a condition usually caused by smoking.
CLTI can cause tissue loss, ulceration, and gangrene, affects around 800,000 people, and accounts for 4,500 amputations each year.
Previous research led by Newcastle University has shown mild anaemia raises the risk of amputation and death by up to 30%, with severity increasing this risk to 50%.
Intravenous (I.V. – injected into a vein) iron is currently used to manage anaemia and improves muscle function in other conditions, however, whether it works in CLTI patients is unknown.
The trial aims to find out if administering I.V. iron shortly after surgery can improve physical health and quality of life for patients. It will be supported by the vascular research team at the Freeman Hospital.
Distinct lack of research
Mr Sandip Nandhra, consultant vascular surgeon at Newcastle Hospitals and senior clinical fellow at Newcastle University, is leading the trial on behalf of ten hospitals across the country. He said:
“Our previous work has identified a distinct lack of research into CLTI recovery, particularly compared to other health conditions, including those that affect the vascular system.
“The impact of CLTI on patients can be far-reaching and very difficult to live with. We need more targeted approaches to support recovery and long‑term rehabilitation.
“We hope that RIVIVAL will contribute to much-needed clinical evidence and reduce the risk to life and limb we see in these patients.”
Patients on the trial will be randomly assigned to receive either IV iron or standard care. The trial will last for 36 months, and further research will be undertaken depending on results.
Professor Danny McAuley, scientific director for NIHR programmes, added:
“Chronic limb-threatening ischaemia is a severe and painful condition affecting 800,000 people and can lead to 4,500 amputations each year.
“This important study aims to improve treatments for these patients and boost their quality of life, as part of the shift from sickness to prevention and highlights how the NIHR is responding to the health and care needs of the nation.
“Now in our 20th year, NIHR is committed to making the biggest impact possible by continuing to address the most significant health and care challenges of our time, and ensuring more people can be part of research.”
Extensive research portfolio
Mr Nandhra is currently in the fourth year of a Newcastle Health Research Partners senior clinical fellow/honorary consultant post. The initiative, jointly funded by Newcastle Hospitals and Newcastle University, allows protected time to develop an extensive research portfolio.
This latest success adds to recent funding from the NIHR to run a first-of-its-kind study to compare two surgical options for acute limb ischaemia, also led by Mr Nandhra.
The study is supported by the Vascular Society of Great Britain and the Society of Vascular Nursing.
