Post-operative iron in cardiac surgery trial - a protocol for a randomised controlled trial

Area of Science:

• Cardiology
• Hematology
• Clinical Trials

Background:

• Anaemia is a common complication after cardiac surgery, negatively impacting patient recovery.
• Effective management of post-operative anaemia is crucial for improving patient well-being and rehabilitation.
• Current treatment strategies for post-cardiac surgery anaemia require further evaluation.

Purpose of the Study:

• To compare the efficacy of single, high-dose intravenous iron therapy against oral iron supplementation.
• To determine the optimal treatment strategy for correcting moderate anaemia following open cardiac surgery.
• To assess the impact of different iron therapies on patient recovery and outcomes.

Main Methods:

• A randomized, active-control superiority trial involving 110 adult patients with moderate anaemia post-cardiac surgery.
• Participants were randomized to receive either high-dose intravenous ferric derisomaltose or standard oral ferrous sulphate.
• Primary outcome: proportion of patients not anaemic or requiring blood transfusions at four weeks.

Main Results:

• The study is ongoing, and results are not yet available.
• Secondary outcomes include changes in haemoglobin, iron biomarkers, exercise capacity, and patient-reported outcomes.
• Cost-effectiveness of each treatment arm will also be evaluated at four weeks.

Conclusions:

• The findings of this trial have the potential to significantly influence the management of anaemia in cardiac surgery patients.
• This research may lead to revised clinical guidelines for post-operative anaemia treatment.
• The study aims to provide evidence-based recommendations for iron therapy in this patient population.