Freeze‐dried plasma: From damage control resuscitation to coronavirus disease 2019 therapy

Peng, Henry T.; Rhind, Shawn G.; Moes, Katy; Devine, Dana V.; Jenkins, Craig; Beckett, Andrew

doi:10.1111/trf.16947

Cited by 3 publications

(1 citation statement)

References 51 publications

(100 reference statements)

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“…Recent efforts to manufacture FDP in plastic bags for transfusion and in vitro characterization have been reported [46]. In this regard, the FDP developed by TerumoBCT (Lakewood, CO) has been characterized by the Canadian Department of Defense through its Defense Research and Development program in collaboration with Canadian Blood Services [47,48,49 ]. The Terumo's FDP products derive from nonpathogen reduced, pools of 10 FFP products.…”

Section: Key Pointsmentioning

confidence: 99%

Novel blood derived hemostatic agents for bleeding therapy and prophylaxis

Hegde

Zheng

Cancelas

2022

Current Opinion in Hematology

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Purpose of reviewHemorrhage is a major cause of preventable death in trauma and cancer. Trauma induced coagulopathy and cancer-associated endotheliopathy remain major therapeutic challenges. Early, aggressive administration of blood-derived products with hypothesized increased clotting potency has been proposed. A series of early- and late-phase clinical trials testing the safety and/or efficacy of lyophilized plasma and new forms of platelet products in humans have provided light on the future of alternative blood component therapies. This review intends to contextualize and provide a critical review of the information provided by these trials.Recent findingsThe beneficial effect of existing freeze-dried plasma products may not be as high as initially anticipated when tested in randomized, multicenter clinical trials. A next-generation freeze dried plasma product has shown safety in an early phase clinical trial and other freeze-dried plasma and spray-dried plasma with promising preclinical profiles are embarking in first-in-human trials. New platelet additive solutions and forms of cryopreservation or lyophilization of platelets with long-term shelf-life have demonstrated feasibility and logistical advantages.Summary:Recent trials have confirmed logistical advantages of modified plasma and platelet products in the treatment or prophylaxis of bleeding. However, their postulated increased potency profile remains unconfirmed.

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Section: Key Pointsmentioning

confidence: 99%

Novel blood derived hemostatic agents for bleeding therapy and prophylaxis

Hegde

Zheng

Cancelas

2022

Current Opinion in Hematology

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Post-Reconstitution Hemostatic Stability Profiles of Canadian and German Freeze-Dried Plasma

Peng,

Moes,

Singh

et al. 2024

Life

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Despite the importance of the hemostatic properties of reconstituted freeze-dried plasma (FDP) for trauma resuscitation, few studies have been conducted to determine its post-reconstitution hemostatic stability. This study aimed to assess the short- (≤24 h) and long-term (≥168 h) hemostatic stabilities of Canadian and German freeze-dried plasma (CFDP and LyoPlas) after reconstitution and storage under different conditions. Post-reconstitution hemostatic profiles were determined using rotational thromboelastometry (ROTEM) and a Stago analyzer, as both are widely used as standard methods for assessing the quality of plasma. When compared to the initial reconstituted CFDP, there were no changes in ROTEM measurements for INTEM maximum clot firmness (MCF), EXTEM clotting time (CT) and MCF, and Stago measurements for prothrombin time (PT), partial thromboplastin time (PTT), D-dimer concentration, plasminogen, and protein C activities after storage at 4 °C for 24 h and room temperature (RT) (22–25 °C) for 4 h. However, an increase in INTEM CT and decreases in fibrinogen concentration, factors V and VIII, and protein S activities were observed after storage at 4 °C for 24 h, while an increase in factor V and decreases in antithrombin and protein S activities were seen after storage at RT for 4 h. Evaluation of the long-term stability of reconstituted LyoPlas showed decreased stability in both global and specific hemostatic profiles with increasing storage temperatures, particularly at 35 °C, where progressive changes in CT and MCF, PT, PTT, fibrinogen concentration, factor V, antithrombin, protein C, and protein S activities were seen even after storage for 4 h. We confirmed the short-term stability of CFDP in global hemostatic properties after reconstitution and storage at RT, consistent with the shelf life of reconstituted LyoPlas. The long-term stability analyses suggest that the post-reconstitution hemostatic stability of FDP products would decrease over time with increasing storage temperature, with a significant loss of hemostatic functions at 35 °C compared to 22 °C or below. Therefore, the shelf life of reconstituted FDP should be recommended according to the storage temperature.

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Dried Plasma for Major Trauma: Past, Present, and Future

Peng,

Singh,

Rhind

et al. 2024

Life

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Uncontrollable bleeding is recognized as the leading cause of preventable death among trauma patients. Early transfusion of blood products, especially plasma replacing crystalloid and colloid solutions, has been shown to increase survival of severely injured patients. However, the requirements for cold storage and thawing processes prior to transfusion present significant logistical challenges in prehospital and remote areas, resulting in a considerable delay in receiving thawed or liquid plasma, even in hospitals. In contrast, freeze- or spray-dried plasma, which can be massively produced, stockpiled, and stored at room temperature, is easily carried and can be reconstituted for transfusion in minutes, provides a promising alternative. Drawn from history, this paper provides a review of different forms of dried plasma with a focus on in vitro characterization of hemostatic properties, to assess the effects of the drying process, storage conditions in dry form and after reconstitution, their distinct safety and/or efficacy profiles currently in different phases of development, and to discuss the current expectations of these products in the context of recent preclinical and clinical trials. Future research directions are presented as well.

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Freeze‐dried plasma: From damage control resuscitation to coronavirus disease 2019 therapy

Cited by 3 publications

References 51 publications

Novel blood derived hemostatic agents for bleeding therapy and prophylaxis

Novel blood derived hemostatic agents for bleeding therapy and prophylaxis

Post-Reconstitution Hemostatic Stability Profiles of Canadian and German Freeze-Dried Plasma

Dried Plasma for Major Trauma: Past, Present, and Future

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