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围手术期输血研究(PETS):在接受非心脏手术的高危心血管患者中,宽松的输血方案是否能改善预后?一项随机对照的初步研究。

Perioperative transfusion study (PETS): Does a liberal transfusion protocol improve outcome in high-risk cardiovascular patients undergoing non-cardiac surgery? A randomised controlled pilot study.

机构信息

Department of Anaesthesiology, Erasmus University Medical Centre, Rotterdam, The Netherlands.

Department of Anaesthesiology, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.

出版信息

Transfus Med. 2024 Oct;34(5):398-404. doi: 10.1111/tme.13058. Epub 2024 Jun 18.

Abstract

BACKGROUND

Small studies have shown that patients with advanced coronary artery disease might benefit from a more liberal blood transfusion strategy. The goal of this pilot study was to test the feasibility of a blood transfusion intervention in a group of vascular surgery patients who have elevated cardiac troponins in rest.

METHODS

We conducted a single-centre, randomised controlled pilot study. Patients with a preoperative elevated high-sensitive troponin T undergoing non-cardiac vascular surgery were randomised between a liberal transfusion regime (haemoglobin >10.4 g/dL) and a restrictive transfusion regime (haemoglobin 8.0-9.6 g/dL) during the first 3 days after surgery. The primary outcome was defined as a composite endpoint of all-cause mortality, myocardial infarction or unscheduled coronary revascularization.

RESULTS

In total 499 patients were screened; 92 were included and 50 patients were randomised. Postoperative haemoglobin was different between the intervention and control group; 10.6 versus 9.8, 10.4 versus 9.4, 10.9 versus 9.4 g/dL on day one, two and three respectively (p < 0.05). The primary outcome occurred in four patients (16%) in the liberal transfusion group and in two patients (8%) in control group.

CONCLUSION

This pilot study shows that the studied transfusion protocol was able to create a clinically significant difference in perioperative haemoglobin levels. Randomisation was possible in 10% of the screened patients. A large definitive trial should be possible to provide evidence whether a liberal transfusion strategy could decrease the incidence of postoperative myocardial infarction in high risk surgical patients.

摘要

背景

小型研究表明,患有晚期冠状动脉疾病的患者可能会从更宽松的输血策略中受益。本试验研究的目的是测试在一组休息时心肌肌钙蛋白升高的血管外科患者中进行输血干预的可行性。

方法

我们进行了一项单中心、随机对照试验研究。术前高敏肌钙蛋白 T 升高的非心脏血管手术患者,在术后前 3 天内随机分为宽松输血组(血红蛋白 >10.4 g/dL)和限制输血组(血红蛋白 8.0-9.6 g/dL)。主要结局定义为全因死亡率、心肌梗死或非计划性冠状动脉血运重建的复合终点。

结果

共筛选了 499 例患者,纳入 92 例,随机分为 50 例。干预组和对照组术后血红蛋白不同;第 1、2 和 3 天分别为 10.6 比 9.8、10.4 比 9.4、10.9 比 9.4 g/dL(p <0.05)。主要结局发生在宽松输血组的 4 例患者(16%)和对照组的 2 例患者(8%)中。

结论

本试验研究表明,所研究的输血方案能够在围手术期血红蛋白水平上产生显著的临床差异。在筛选的患者中,10%可以进行随机分组。应该有可能进行大规模的确定性试验,以提供证据表明宽松的输血策略是否可以降低高危手术患者术后心肌梗死的发生率。

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