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

INTRODUCTION: Anaemia is common after cardiac surgery and has a negative impact on rehabilitation and patient well-being. We aim to compare the efficacy of single, high-dose intravenous iron therapy versus oral iron supplementation to correct anaemia following open cardiac surgery. METHODS: We present a randomised, active-control superiority trial. Adult patients with moderate anaemia (haemoglobin 5.0-6.8 mmol/l) on the first post-operative day after first-time, non-emergent cardiac surgery are eligible. After stratification by gender, 110 patients are randomised 1:1 to either single, high-dose intravenous iron therapy (20 mg/kg ferric derisomaltose) or oral iron supplementation (100 mg ferrous sulphate orally twice daily). The primary outcome measure at the four-week follow-up is the proportion of participants who are neither anaemic (haemoglobin less-than 8.1 mmol/l in men and less-than 7.5 mmol/l in women) nor have received allogeneic red blood cells since randomisation. Secondary outcome measures include changes in haemoglobin and iron biomarkers, exercise capacity, patient-reported outcome measures and cost of care at the four-week follow-up. CONCLUSION: The results of the PICS trial may fundamentally alter future management of anaemia following cardiac surgery. FUNDING: The study is supported by Aarhus University Hospital, an unrestricted research grant by Pharmacosmos A/S (Holbæk, Denmark) and an independent grant from the Health Research Foundation of the Central Denmark Region (ISM). TRIAL REGISTRATION: EudraCT number: 2020-001389-12; Clinical Trials ID: NCT04608539.

Autotransfusion of a restricted volume of shed mediastinal blood does not affect the haemostatic capacity in patients following cardiac surgery.

UNLABELLED: The aim was to investigate the haemostatic capacity after autotransfusion of shed mediastinal blood in patients following cardiac surgery. Fifteen cardiac surgery patients with a chest tube drainage ≥ 300 mL blood within the first 6 hours postoperatively were included. The haemostatic capacity was evaluated using whole blood thromboelastometry (ROTEM(®)), impedance aggregometry (Multiplate(®)) and conventional coagulation tests. Measurements were carried out in (1) mediastinal blood, and in blood samples obtained, (2) before autotransfusion, and (3) after autotransfusion of mediastinal blood. In shed mediastinal blood, ROTEM(®) analyses showed reduced clot firmness in the EXTEM (p < 0.001), INTEM (p < 0.001), and FIBTEM assay (p = 0.002). Platelet function and conventional coagulation parameters were significantly impaired (p < 0.001). However, ROTEM(®), platelet function and conventional coagulation tests remained unchanged after autotransfusion. CONCLUSION: Shed mediastinal blood has a substantially reduced haemostatic capacity, but autotransfusion of an average of 350 mL did not affect the overall haemostatic capacity.