Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman
{"title":"An experimental comparison and user evaluation of three different dried plasma products.","authors":"Kristina Ehn, Gabriel Skallsjö, Birgitta Romlin, Göran Sandström, Per Sandgren, Agneta Wikman","doi":"10.1111/vox.13798","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objectives: </strong>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.</p><p><strong>Materials and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":23631,"journal":{"name":"Vox Sanguinis","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vox Sanguinis","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/vox.13798","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
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.
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.