IF 1.8 4区 医学 Q3 HEMATOLOGY
Vox Sanguinis Pub Date : 2025-01-27 DOI:10.1111/vox.13798
Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman
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引用次数: 0

摘要

背景和目的:在院前出血抢救中获取血液成分具有挑战性。干血浆在后勤方面是一种优越的替代品,而且新产品不断涌现。因此,我们旨在评估三种不同生产方式的干血浆产品在实验室和实用性方面的差异:分析了单供体冻干 LyoPlas®、集合供体冻干和病原体还原 OctaplasLG Powder®、单供体喷雾干燥 FrontlineODP™ 以及作为对照的新鲜血浆(内部、前 FrontlineODP 和 OctaplasLG)(n = 8)。实验室检测包括各种凝血因子和血栓弹性成像的测量。对干血浆产品的实际评估包括制备时间、干血浆溶解时间和总时间,以及八位临床用户的主观意见:结果:所有干血浆的凝血因子含量都在人体参考范围内,与新鲜血浆相比,大约损失 10%-20%。与集合产品相比,单供体产品的差异更大。血栓弹力图分析显示血栓形成情况正常。重组时间相似,平均为 7-9 分钟。在用户评估中,重组时间和使用塑料袋输血的可能性被强调为非常重要,其中有两种产品满足了后者的要求:这项研究证明,干血浆可通过冻干或喷雾干燥技术以及病原体减毒技术生产,并能保持凝血能力。这些产品可在可接受的时间内重组,并被第八位测试用户认为可在院前使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
An experimental comparison and user evaluation of three different dried plasma products.

Background and objectives: Access to blood components in pre-hospital bleeding resuscitation is challenging. Dried plasma is a logistically superior alternative, and new products are emerging. Therefore, we aimed to evaluate laboratory and practical differences in three differently produced dried plasma products.

Materials and methods: Single-donor lyophilized LyoPlas®, pooled-donor, lyophilized and pathogen-reduced OctaplasLG Powder®, and single-donor sprayed-dried FrontlineODP™ along with fresh plasma (in-house, pre-FrontlineODP and OctaplasLG) as controls were analysed (n = 8). Laboratory tests included measurements of various coagulation factors and thromboelastography. The practical evaluation of the dried plasma products included preparation time, time to dissolve the dried plasma and total time, together with subjective opinions from eight clinical users.

Results: The coagulation factor content was within human reference ranges for all dried plasma, with approximately 10%-20% loss compared with fresh plasma. More variations were observed in the single-donor products compared with the pooled products. Clot formation analysed by thromboelastography showed normal graphs. Reconstitution time was similar, ranging from on average 7-9 min. In the user evaluation, the reconstitution time and the possibility of using a plastic bag for the transfusion were emphasized as important, the latter fulfilled by two of the products.

Conclusion: The study supports that dried plasma may be produced with lyophilization or spray-drying technique, as well as with the addition of pathogen reduction, with preserved coagulation capability. The products were reconstituted in acceptable time and deemed feasible for pre-hospital use by eighth test users.

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来源期刊
Vox Sanguinis
Vox Sanguinis 医学-血液学
CiteScore
4.40
自引率
11.10%
发文量
156
审稿时长
6-12 weeks
期刊介绍: Vox Sanguinis reports on important, novel developments in transfusion medicine. Original papers, reviews and international fora are published on all aspects of blood transfusion and tissue transplantation, comprising five main sections: 1) Transfusion - Transmitted Disease and its Prevention: Identification and epidemiology of infectious agents transmissible by blood; Bacterial contamination of blood components; Donor recruitment and selection methods; Pathogen inactivation. 2) Blood Component Collection and Production: Blood collection methods and devices (including apheresis); Plasma fractionation techniques and plasma derivatives; Preparation of labile blood components; Inventory management; Hematopoietic progenitor cell collection and storage; Collection and storage of tissues; Quality management and good manufacturing practice; Automation and information technology. 3) Transfusion Medicine and New Therapies: Transfusion thresholds and audits; Haemovigilance; Clinical trials regarding appropriate haemotherapy; Non-infectious adverse affects of transfusion; Therapeutic apheresis; Support of transplant patients; Gene therapy and immunotherapy. 4) Immunohaematology and Immunogenetics: Autoimmunity in haematology; Alloimmunity of blood; Pre-transfusion testing; Immunodiagnostics; Immunobiology; Complement in immunohaematology; Blood typing reagents; Genetic markers of blood cells and serum proteins: polymorphisms and function; Genetic markers and disease; Parentage testing and forensic immunohaematology. 5) Cellular Therapy: Cell-based therapies; Stem cell sources; Stem cell processing and storage; Stem cell products; Stem cell plasticity; Regenerative medicine with cells; Cellular immunotherapy; Molecular therapy; Gene therapy.
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