An experimental comparison and user evaluation of three different dried plasma products

对三种不同的干血浆制品进行实验比较和用户评价

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Abstract

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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