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院前输血经多次空中救援任务运输后的非劣效红细胞浓缩物质量

Noninferior Red Cell Concentrate Quality after Repeated Air Rescue Mission Transport for Prehospital Transfusion.

作者信息

Boecker Clemens, Sitzmann Nicole, Halblaub Miranda Jose Luis, Suhr Hajo, Wiedemann Philipp, Bieback Karen, Rudolph Marcus, Klüter Harald

机构信息

Department of Biotechnology, Mannheim University of Applied Sciences, Mannheim, Germany.

Institute of Transfusion Medicine and Immunology, German Red Cross Blood Service, Baden-Württemberg - Hessen, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.

出版信息

Transfus Med Hemother. 2022 Feb 15;49(3):172-179. doi: 10.1159/000520650. eCollection 2022 Jun.

Abstract

BACKGROUND

Transfusion of red cell concentrates (RCCs) is an integral therapy after severe hemorrhage or trauma. Prehospital transfusion offers an immediate intervention in emergency cases. Air ambulance-based prehospital transfusion, already used in different countries, is currently established in Germany. Limited information is available for regulatory-compliant transport logistics of RCCs and their quality after repeated air rescue missions. Thus, the aim of this study was (i) to validate regulatory-compliant logistics and (ii) to assess product quality, analyzing biochemical parameters and RBC morphology.

STUDY DESIGN AND METHODS

Due to regulatory requirements, we adapted a rotation system of 1 day transport, 1 day quarantine storage and 1 day storage over the entire RCC shelf life. RCCs transported on air rescue missions (flight group) were compared against a control group, treated identically except for helicopter transport. RCCs were visually inspected, and their temperature was documented throughout the entire rotation cycles. RCCs at the end of shelf life (end point samples) were assessed for levels of hemoglobin, hematocrit, free hemoglobin, hemolysis, mean corpuscular volume, potassium and pH. In addition, morphological changes were assessed using flow morphometry.

RESULTS

In total 81 RCCs were assessed in the flight group and 50 in the control group. Within the flight group, 30 RCCs were transfused. RCCs were dispatched on average 11 times (7-13 times). The average flight time was 18.3 h (6.6-28.8 h). The rotation system ensured adherence to regulatory guidelines, especially compliance to storage conditions of +2 to +6°C of intermediate storage. Biochemical and morphological quality parameters did not exhibit any changes upon repeated air rescue missions. A correlation with respect to the flight time was not observed either.

DISCUSSION

The quality of RCCs after repeated air rescue missions is noninferior to control samples regarding biochemical and morphological parameters. The product quality is within German regulations for up to 42 days of storage. The logistics and maintenance of the thermal conditions are safe and feasible. Thus, a rotation system of RCCs offers a regulatory-compliant option to supply air rescue missions with RCCs to allow life-saving prehospital transfusions at the incident scene.

摘要

背景

红细胞浓缩液(RCCs)输血是严重出血或创伤后的一项重要治疗手段。院前输血能在紧急情况下提供即时干预。基于空中救护的院前输血在不同国家已被采用,目前在德国也已确立。关于RCCs符合监管要求的运输物流及其在多次空中救援任务后的质量,相关信息有限。因此,本研究的目的是:(i)验证符合监管要求的物流;(ii)通过分析生化参数和红细胞形态来评估产品质量。

研究设计与方法

由于监管要求,我们在RCCs的整个保质期内采用了1天运输、1天检疫储存和1天储存的轮转系统。将空中救援任务中运输的RCCs(飞行组)与对照组进行比较,对照组除了不进行直升机运输外,其他处理相同。对RCCs进行目视检查,并在整个轮转周期记录其温度。在保质期结束时的RCCs(终点样本)评估血红蛋白、血细胞比容、游离血红蛋白、溶血、平均红细胞体积、钾和pH值水平。此外,使用流式形态计量学评估形态变化。

结果

飞行组共评估了81份RCCs,对照组评估了50份。在飞行组中,30份RCCs被输注。RCCs平均被派遣11次(7 - 13次)。平均飞行时间为18.3小时(6.6 - 28.8小时)。轮转系统确保了符合监管指南,特别是符合中间储存2至6°C的储存条件。重复空中救援任务后,生化和形态质量参数未出现任何变化。也未观察到与飞行时间的相关性。

讨论

在生化和形态参数方面,多次空中救援任务后的RCCs质量不低于对照样本。产品质量在德国法规规定的长达42天储存期内符合要求。热条件的物流和维持是安全可行的。因此,RCCs的轮转系统提供了一种符合监管要求的选择,为空中救援任务提供RCCs,以便在事故现场进行挽救生命的院前输血。

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