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使用新生儿小中心静脉导管进行红细胞输血的安全性:一项非劣效性研究。

Safety of Red Blood Cell Transfusion Using Small Central Lines in Neonates: An Non-inferiority Study.

作者信息

Rosa-Mangeret Flavia, Waldvogel-Abramowski Sophie, Pfister Riccardo E, Baud Olivier, Fau Sébastien

机构信息

Division of Neonatology, Geneva University Hospital (HUG), Geneva, Switzerland.

Division of Hematology, Geneva University Hospital (HUG), Geneva, Switzerland.

出版信息

Front Pediatr. 2021 Mar 3;9:606611. doi: 10.3389/fped.2021.606611. eCollection 2021.

Abstract

This study aimed to investigate the safety of transfusing red blood cell concentrates (RBCCs) through small [24 gauge (24G)] and extra-small [28 gauge [28G)] peripherally inserted central catheters (PICCs), according to guidelines of transfusion practice in Switzerland. We performed a non-inferiority study to assess the safety of transfusing RBCC for 4 h at a 4 ml/h speed through 24G silicone and 28G polyurethane PICC lines, compared with a peripheral 24G short catheter. The primary endpoint was hemolysis percentage. Secondary endpoints were catheter occlusion, inline pressure, and potassium and lactate values. For the primary outcome, hemolysis values were not statistically different among catheter groups (0.06% variation, = 0.95) or over time (2.75% variation, = 0.72). The highest hemolysis values in both 24G and 28G PICCs were below the non-inferiority predefined margin. We did not observe catheter occlusion. Inline pressure varied between catheters but followed the same pattern of rapid increase followed by stabilization. Potassium and lactate measurements were not statistically different among tested catheters (0.139% variation, = 0.98 for potassium and 0.062%, = 0.96 for lactates). This study shows that RBCC transfusion performed through 24G silicone and 28G polyurethane PICC lines is feasible without detectable hemolysis or pressure concerns. Also, it adds that, concerning hemolysis, transfusion of RBCC in small and extra-small PICC lines is non-inferior to peripheral short 24G catheters. Clinical prospective assessment in preterm infants is needed to confirm these data further.

摘要

本研究旨在根据瑞士输血实践指南,调查通过小号[24号(24G)]和超小号[28号(28G)]外周静脉穿刺中心静脉导管(PICC)输注红细胞浓缩液(RBCC)的安全性。我们进行了一项非劣效性研究,以评估通过24G硅胶和28G聚氨酯PICC导管以4 ml/h的速度输注RBCC 4小时的安全性,并与外周24G短导管进行比较。主要终点是溶血百分比。次要终点是导管堵塞、管内压力以及钾和乳酸值。对于主要结局,各导管组之间的溶血值无统计学差异(变异率为0.06%,P = 0.95),且随时间变化也无差异(变异率为2.75%,P = 0.72)。24G和28G PICC导管的最高溶血值均低于预先设定的非劣效性界限。我们未观察到导管堵塞。不同导管的管内压力有所不同,但都呈现出先快速升高然后稳定的相同模式。所测试的导管之间钾和乳酸的测量值无统计学差异(钾的变异率为0.139%,P = 0.98;乳酸的变异率为0.062%,P = 0.96)。本研究表明,通过24G硅胶和28G聚氨酯PICC导管进行RBCC输血是可行的,不会出现可检测到的溶血或压力问题。此外,该研究还补充指出,就溶血而言,在小号和超小号PICC导管中输注RBCC并不劣于外周24G短导管。需要对早产儿进行临床前瞻性评估以进一步证实这些数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/69c4/7968454/a9ce8a1907ac/fped-09-606611-g0001.jpg

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