Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark.
Dan Med J. 2022 Jun 24;69(7):A12210952.
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.
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.
The results of the PICS trial may fundamentally alter future management of anaemia following cardiac surgery.
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).
EudraCT number: 2020-001389-12; Clinical Trials ID: NCT04608539.
心脏手术后贫血很常见，对康复和患者的幸福感有负面影响。我们旨在比较单次高剂量静脉铁治疗与口服铁补充剂纠正开胸心脏手术后贫血的疗效。
我们进行了一项随机、阳性对照优效性试验。在首次非紧急心脏手术后第一天，血红蛋白为 5.0-6.8mmol/L 的中度贫血成年患者符合入组条件。按照性别分层后，110 名患者以 1:1 的比例随机分为单次高剂量静脉铁治疗（20mg/kg 三价柠檬酸铁）或口服铁补充剂（100mg 硫酸亚铁口服，每日两次）。四周随访时的主要结局指标是既不贫血（男性血红蛋白<8.1mmol/L，女性血红蛋白<7.5mmol/L）也未接受自随机分组以来异体红细胞输注的参与者比例。次要结局指标包括血红蛋白和铁生物标志物的变化、运动能力、患者报告的结局指标以及四周随访时的护理费用。
PICS 试验的结果可能从根本上改变心脏手术后贫血的未来管理。
该研究由奥胡斯大学医院、丹麦 Pharmacosmos A/S（霍尔贝克）的一项不受限制的研究赠款以及丹麦中央大区健康研究基金会（ISM）的一项独立赠款资助。
EudraCT 编号：2020-001389-12；临床试验注册号：NCT04608539。
