Freeze-dried plasma for emergency transfusion care in extreme conditions

Introduction. In the context of limited availability of fresh frozen plasma, the use of freeze-dried plasma offers significant logistical advantages in extreme conditions. The effectiveness of freeze-dried plasma depends on the preservation of coagulation potential in the manufacturing process.

Objective. Review of research achievements both in Russia and aboard in the field of freeze-dried plasma technologies, including manufacturing, quality control, and blood component application.

Discussion. Commercial products such as FLyP, LyoPlas N-w, Bioplasma FDP, OctaplasLG Lyo, as well as freeze-dried plasma (Belarus or China), which have proven their effectiveness and safety, are available in glass vials. The production of freeze-dried plasma in polymer containers using membrane technology is a promising direction offering the advantage of using blood components in extreme conditions. The freeze-dried plasma products developed by Terumo BCT Biotechnologies and Teleflex Inc. are currently undergoing clinical trials and are used in military operations to a limited extent. In the Russian Federation, the Lyokon polymer container has been registered. During the lyophilization process, the pH increases to alkaline pH values of 8, which is associated with the removal of carbon dioxide. When assessing the coagulation potential, the most significant decrease is observed in the activity of factor VIII — up to 50%, factor V — up to 37%, protein S — up to 34%, and von Willebrand Factor — up to 25%. The prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) is noted. In the Russian Federation, freeze-dried plasma belongs to the group of blood components; therefore, the introduction of foreign production experience (the introduction of cryo- and lyoprotectors, pH adjustment, etc.) is restrained by legislation. This emphasizes the importance of developing domestic technologies.

Conclusions. The production of freeze-dried plasma in polymer containers contributes to uninterrupted transfusion support in the provision of medical care, thus increasing the survival rate of the injured with acute blood loss in emergency situations. In this regard, creation of domestic plasma lyophilization technologies and enhancement of their effectiveness are relevant tasks.

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