一组护理措施（静脉注射铁剂、促红细胞生成素和输血代谢调整）对心脏手术术后输血发生率的影响：一项单中心、随机、开放标签、平行组对照的试点试验。
Impact of a bundle of care (intravenous iron, erythropoietin and transfusion metabolic adjustment) on post-operative transfusion incidence in cardiac surgery: a single-centre, randomised, open-label, parallel-group controlled pilot trial.
作者信息
Saour Marine, Blin Cinderella, Zeroual Norddine, Mourad Marc, Amico Maïlis, Gaudard Philippe, Picot Marie-Christine, Colson Pascal H
机构信息
Anaesthesiology and Critical Care Medicine Department, Arnaud de Villeneuve Hospital, University of Montpellier Hospital Centre, University of Montpellier, Montpellier, France.
Clinical Research and Epidemiology Unit, University of Montpellier Hospital Centre, University of Montpellier, Montpellier, France.
出版信息
Lancet Reg Health Eur. 2024 Jun 24;43:100966. doi: 10.1016/j.lanepe.2024.100966. eCollection 2024 Aug.
BACKGROUND
Red blood cell (RBC) transfusions are frequent in patients after cardiac surgery. This study assessed whether a bundle of care including pre-operative and post-operative administration of erythropoietin (EPO) with intravenous iron supplementation, and restrictive transfusion adjusted for ScvO could result in reduced postoperative transfusions.
METHODS
In this single-centre, randomised, open-label, parallel-group controlled pilot study, patients undergoing elective cardiac surgery with high risk of transfusion in a University Hospital were enrolled by the investigator and the randomisation procedure using a central internet-based system was made by the clinical research assistant. Since the trial was open-label, no masking was used. Patients were assigned (1:1) to either the STOP group (40,000 IU subcutaneous EPO combined with 20 mg/kg intravenous ferric carboxymaltose if Hb < 13 g/dL the day before surgery or at ICU admission, and RBC transfusion if Hb ≤ 8 g/dL and ScvO ≤ 65%, or additional EPO dose if 8 < Hb < 13 g/dL) or to the control group (RBC transfusion if Hb ≤ 8 g/dL, or, if 8 < Hb < 13 g/dL, intravenous iron sucrose 200 mg or 300 mg according to weight). Primary outcome was the incidence of postoperative RBC transfusion up to hospital discharge or postoperative day 28. The trial is registered with ClinicalTrials.gov, NCT04141631.
FINDINGS
Between Jan 20, 2020, and Sept 6, 2022, among 128 patients enrolled, 123 (male, 54.4%, 67/123) were included in the full analysis set: 62 in the STOP group and 61 in the control group. Nine patients (14.5%, 9/62) in the STOP group required RBC transfusion vs 19 (31.2%, 19/61) in the control group (odds ratio 0.37 [95% CI: 0.15-0.91], p = 0.03). The median length of follow up to transfusion was 2.6 days (1.5; 4.6) and 3.3 (1.6; 4.2) in control and STOP groups respectively (p = 0.61).
INTERPRETATION
The bundle of care may reduce postoperative RBC transfusion. The findings should be taken with caution due to the unblinded and exploratory nature of the study.
FUNDING
University of Montpellier Hospital and Vifor Pharma.
背景
心脏手术后患者经常需要输注红细胞（RBC）。本研究评估了一套护理方案，包括术前和术后给予促红细胞生成素（EPO）并静脉补充铁剂，以及根据中心静脉血氧饱和度（ScvO）调整的限制性输血策略，是否能减少术后输血。
方法
在这项单中心、随机、开放标签、平行组对照的试点研究中，由研究者招募在大学医院接受择期心脏手术且输血风险高的患者，并由临床研究助理使用基于互联网的中央系统进行随机分组。由于试验为开放标签，未采用盲法。患者按1:1随机分配至STOP组（术前一天或入住重症监护病房（ICU）时血红蛋白（Hb）<13 g/dL，皮下注射40000 IU EPO并静脉注射20 mg/kg羧麦芽糖铁；Hb≤8 g/dL且ScvO≤65%时输注RBC；8<Hb<13 g/dL时额外给予EPO剂量）或对照组（Hb≤8 g/dL时输注RBC；8<Hb<13 g/dL时，根据体重静脉注射200 mg或300 mg蔗糖铁）。主要结局是至出院或术后28天的术后RBC输血发生率。该试验已在ClinicalTrials.gov注册，注册号为NCT04141631。
结果
在2020年1月20日至2022年9月6日期间，纳入的128例患者中，123例（男性，54.4%，67/123）纳入全分析集：STOP组62例，对照组61例。STOP组9例患者（14.5%，9/62）需要输注RBC，而对照组为19例（3l.2%，19/61）（比值比0.37 [95%CI：0.15 - 0.91]，p = 0.03）。对照组和STOP组至输血的中位随访时间分别为2.6天（1.5；4.6）和3.3天（1.6；4.2）（p = 0.61）。
解读
该护理方案可能减少术后RBC输血。由于本研究的非盲法和探索性性质，这些结果应谨慎看待。
资助
蒙彼利埃大学医院和维福制药公司。
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