A05 Dried plasma for combat casualty care far forward: a comparative overview and experimental study
Notice bibliographique
Résumé
Introduction Uncontrolled bleeding, often accompanied by trauma-induced coagulopathy, is the leading cause of preventable deaths on the battlefield. 1 Notably, 87% of military personnel who die from their injuries do so before reaching a definitive medical treatment facility. 2 Remote Damage Control Resuscitation (RDCR) with blood products is therefore recommended at the earliest possible time after combat injuries. 3 Dried plasma (DP) presents a promising alternative to fresh frozen plasma or liquid thawed plasma for RDCR in austere environments, owning to its long shelf life at ambient temperatures, ease of transport, and rapid reconstitution and administration. 4 In recent years, the Canadian Armed Forces (CAF) in collaboration with Canadian Blood Services (CBS) and Defence Research and Development Canada (DRDC), have developed freeze-dried plasma (FDP) from Canadian-sourced plasma. 5 DRDC has evaluated several DP products produced using different technologies and plasma sources. This presentation will provide a brief overview of current status of DP, followed by a comparative analysis of different DP products, with a focus on their haemostatic profiles. Methods We conducted a literature review encompassing both laboratory and clinical studies. The haemostatic capabilities of four DP products - Canadian FDP (CFDP), LyoPlas, OctaplasLG Powder, and Frontline On Demand Plasma (ODP) – were compared using global haemostatic tests (rotational thromboelastometry) and specific factor assays (Stago analyzer). Results A number of DP products are available, produced by either freeze-drying or spray-drying methods from different plasma sources (figure 1). Among these products, four FDP products have been approved for human use: FLyP, LyoPlas, Bioplasma FDP, and OctaplasLG Powder. All of these are freeze-dried in glass bottles and produced by central production facility but differ in their plasma sources. FLyP, Bioplasma FDP, OctaplasLG Powder are produced from pooled, pathogen-reduced plasma, while LyoPlas is made from single-donor plasma that is quarantined for at least four months and tested negative for HIV and hepatitis B and C virus. FLyP and LyoPlas have been fielded by armed forces and extensively evaluated in clinical settings, including randomized controlled trials, demonstrating excellent safety and feasibility for prehospital transfusion. 6 Newer DP products are now packaged in plastic bags, offering improved durability and suitability for remote or harsh environments. Notably, Frontline ODP, developed by Velico Medical, is produced using a proprietary spray-drying process from a single unit of non-pathogen-reduced fresh plasma. It has received FDA approval to proceed with a phase I clinical study. 7 All evaluated DP products demonstrated haemostatic performance within normal human reference intervals. While differences were observed in both global haemostasis and several specific coagulation factor and inhibitor levels, 8–11 these variations are unlikely to be of clinical significance. Conclusions Several DP products are currently available, differing in their plasma sources, drying processes, and in vitro haemostatic properties. Although the capabilities of current DP products vary across NATO countries, there is a strong and shared interest in the deployment of DP for forward combat casualty care. This creates a strategic opportunity for collaboration, standardization, and interoperability across allied nations. Competing interests None declared. References Mazuchowski EL, Kotwal RS, Janak JC, et al . Mortality review of US special operations command battle-injured fatalities. J Trauma Acute Care Surg . 2020; 88 (5):686–95. Webster S, Barnard EBG, Smith JE, et al . Killed in action (KIA): an analysis of military personnel who died of their injuries before reaching a definitive medical treatment facility in Afghanistan (2004–2014). BMJ Mil Health . 2021; 167 (2):84–88. Department of Defence. Clinical practice guidelines [online]. 2023 https://jts.health.mil/index.cfm/PI_CPGs/cpgs (accessed 30 April 2023). Peng HT, Singh K, Rhind SG, et al . Dried plasma for major trauma: past, present, and future. Life (Basel) . 2024; 14 (5):619–54. Peng HT, Rhind SG, Devine D, et al . Ex vivo hemostatic and immuno-inflammatory profiles of freeze-dried plasma. Transfusion . 2021; 61 Suppl 1:S119–S30. Sheffield WP, Singh K, Beckett A, Devine DV. Prehospital freeze-dried plasma in trauma: A critical review. Transfus Med Rev . 2024; 38 (1):150807. Velico Medical Inc. FrontlineODP™ [online]. 2023. https://www.veli.co/frontlineodp (accessed 15 December 2023). Peng HT, Rhind SG, Moes K, et al . Freeze-dried plasma: from damage control resuscitation to coronavirus disease 2019 therapy. Transfusion . 2022; 62 (7):1408–16. Peng HT, Moes K, Singh K, et al . Post-reconstitution hemostatic stability profiles of Canadian and German freeze-dried plasma . Life. 2024; 14 (2):172–85. Ehn K, Skallsjo G, Romlin B, et al . An experimental comparison and user evaluation of three different dried plasma products. Vox Sang. 2025. Shoara AA, Singh K, Peng HT, et al . Freeze-dried plasma: hemostasis and biophysical analyses for damage control resuscitation. Transfusion. 2025; 65 :Suppl 1(Suppl 1):S250–S64. Abstract A05 Figure 1 Currently available dried plasma products.4 FLyP is a freeze-dried plasma (FDP) product manufactured by the French Blood Bank using small donor pools (<11 donors) and pathogen reduction via amotosalen and UV light. It has been used by the French military since 1994 and by the U.S. military since 2018. Bioplasma FDP, produced from solvent/detergent (S/D)-treated pooled plasma from up to 1,500 donors by the National Bioproducts Institute of South Africa, has been used in the general population in South Africa and neighbouring countries since 1996. TFDP is an FDP product under development by Terumo BCT. CFDP, similar to TFDP, is produced by Canadian Blood Services using Canadian-sourced plasma. OctaplasLG Powder is a pooled (630–1,520 donors), S/D pathogen-reduced FDP manufactured by Octapharma and has recently been approved by European medical authorities. Resusix is a pooled (100–150 donors), S/D pathogen-reduced spray-dried plasma (SDP) product developed by Entegrion and has undergone phase I clinical trials. LyoPlas is a single-donor, non-pathogen-reduced FDP produced by the German Red Cross, used by the German, Israeli, and UK militaries, as well as in civilian settings. EXPLAZ, a single-donor FDP from Teleflex, has been evaluated in a clinical dose-escalation safety trial. Frontline On Demand Plasma (ODP) is a single-donor, non-pathogen-reduced SDP product developed by Velico Medical using a proprietary spray-drying system
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Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
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