Introduction
In major surgery, it is unclear whether the use of intravenous (IV) iron to treat anaemia can provide a direct benefit to patients. We aimed to assess the effect of IV iron administration during major surgery on muscle function and quality of life (QoL) outcomes.
Methods
Adult patients with anaemia, defined as haemoglobin concentration (Hb) <120g/L for women and <130g/L for men, undergoing major lower limb vascular surgery were included from a single centre. Patients were randomised 1:1 in a double-blinded manner, to receive 1000mg of ferric carboxymaltose (FCM) or placebo (saline). The primary outcome was Hb at 30-days post-operation. Secondary outcomes included QoL assessments (EQ-5D-5DL and SF-36) and hand grip strength (GS). Trial registration: ACTRN12622001447741.
Results
Of 26 recruited patients:12 were allocated to FCM and 14 to placebo. Mean age was 64.7 ±11.7years and 15% were female. Baseline Hb was similar (FCM: 107.6 ±15.8g/L vs placebo: 113.9 ±16.0g/L, p=0.327), with no difference by 30-days post-operation (109 ±9.6g/L vs 112.1 ±17.7g/L, p=0.609). By day 30, there was no difference in GS (26.6 ±13.6 vs 25.8 ±14.3, p=0.918). From day 8 to 30, no significant difference was observed between groups in change of GS (-6.4 ±18.5 vs -14.1 ±15.9, p=0.270) nor EQ-5D-5L visual analogue score (-12.4 ±33.8 vs 3.14 ±24.1, p=0.720). No difference was observed in any QoL components between the groups.
Conclusions
The use of IV iron peri-operatively did not improve Hb, QoL outcomes or GS by 30 days post-operation. Long-term re-evaluation of these outcomes is required.