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Randomised Intravenous Iron After Revascularisation in Anaemic Chronic Limb-Threatening Ischaemia (RIVIVAL)

Background

Peripheral arterial disease (PAD) affects one in five people over 55. This is where fat and other substances build up inside the arteries (known as atherosclerosis), making it harder for blood to flow. In severe cases, there is not enough blood flow to a limb, often the legs and feet. This can lead to pain, ulcers and tissue loss in the affected limb. This is called chronic limb-threatening ischaemia (CLTI). CLTI increases the risk of limb loss and death, even after treatment.
Current treatment involves surgery (revascularisation) to return blood flow to the affected limb. Despite this, short and long-term patient outcomes are often poor. One reason for this is that CLTI affects the whole body, with many patients weak from muscle loss and widespread inflammation. Moreover, half of patients have low haemoglobin and iron levels (anaemia) at diagnosis. This rises to 80% at discharge from hospital. Research has shown that mild anaemia raises the risk of leg loss or death by nearly 30%, a figure which rises to 50% for moderate to severe anaemia. Surgery alone does not fix these problems. Currently, there are no approved treatments to target these wider issues. 

The Study

The study will explore whether giving iron through a drip (IV iron) after surgery will improve the physical performance and/or quality of life of anaemic CLTI patients.

Study Design

This is a multi-centre, parallel-group, double-blind, randomised, placebo-controlled trial.
This means several hospitals are running the study. Participants are randomly assigned to either the iron after surgery group or a placebo (inactive treatment) group. Neither the participants nor the study team know who is in which group. 

Who Can Take Part? 

Consenting adults (age ≥18 years) with chronic limb-threatening ischaemia (CLTI) and anaemia.

Recruitment 

We aim to recruit 254 participants across 7 UK NHS hospitals. 

Primary Outcome

Physical performance will be assessed by grip strength 8-weeks post-administration. Participants will also be asked to complete a quality-of-life questionnaire (VascuQoL).