Dried Plasma

Zaza, Mouayyad; Kalkwarf, Kyle J.; Holcomb, John B.

doi:10.1007/978-3-030-20820-2_8

Cited by 6 publications

(15 citation statements)

References 86 publications

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“…31,55 These logistic (reduced weight and cube) and other potential therapeutic advantages have led to renewed interest in the use of FDP, particularly in austere far-forward military trauma environments. 47,49,50 This study assessed the in vitro coagulation and immuno-inflammatory characteristics of a novel TFDP product versus conventional FFP. Our findings show that TFDP is equivalent to its primary FP source with respect to hemostatic and inflammatory mediator profiles.…”

Section: Discussionmentioning

confidence: 99%

“…92,93 Overall, these results reinforce that preparation of human plasma in the dried state, facilitate long-term storage under ambient conditions, providing an important alternative approach where cryogenic preservation and transport are not an option (e.g., out of hospital settings, battlefield care, or areas with limited infrastructure). 50 This study was focused on global hemostasis and immuno-inflammatory profiles of TFDP, other properties e.g., specific coagulation factors and inhibitors, complement components, were assessed in a separate study. 45 A further comparison of our FDP with FFP for reconstitution of whole blood may also be important to support its use for hemostatic resuscitation in severe trauma along with superior logistical properties.…”

Section: Discussionmentioning

confidence: 99%

“…Currently, three different FDP products are commercially available across Europe and South Africa for use in trauma and critical: 46,50 French lyophilized plasma (FLYP) manufactured by the French Blood Bank from approximately 10 carefully screened and monitored donors; German lyophilized plasma (LyoPlas) manufactured by the German Red Cross from a single donor quarantined for at least 4 months and negatively tested for human immunodeficiency virus and hepatitis B and C virus; Bioplasma FDP produced by the National Bioproducts Institute of South Africa from hundreds of donors (up to 1500). The first two products have been used in prehospital settings 43,55,73 .…”

Section: Discussionmentioning

confidence: 99%

“…48,49 Although Germany, France, and South Africa currently use an FDP product, the US Food and Drug Administration and Health Canada have yet to approve this product for human use and additional randomized studies of FDP are needed to conclusively document clinical benefit in major trauma. 50,51 Terumo BCT has developed an FDP production system (referred to as Terumo's freeze-dried plasma product [TFDP]) that can be used in a blood center environment and stored in a rugged, lightweight plastic package with long stability, easy-to-carry, and fast reconstitution suitable for field use although further studies are needed to determine its clinical benefits. In collaboration with Canadian Blood Services (CBS) and Defense Research and Development Canada, Canadian Forces Health Services is evaluating TFDP for potential use in civilian and military trauma care.…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, recent systematic reviews and meta‐analysis of FDP for major trauma and hemorrhage found no difference in mortality and transfusion of allogeneic blood products in patients receiving FDP compared to FFP 48,49 . Although Germany, France, and South Africa currently use an FDP product, the US Food and Drug Administration and Health Canada have yet to approve this product for human use and additional randomized studies of FDP are needed to conclusively document clinical benefit in major trauma 50,51 . Terumo BCT has developed an FDP production system (referred to as Terumo's freeze‐dried plasma product [TFDP]) that can be used in a blood center environment and stored in a rugged, light‐weight plastic package with long stability, easy‐to‐carry, and fast reconstitution suitable for field use although further studies are needed to determine its clinical benefits.…”

Section: Introductionmentioning

confidence: 99%

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Ex vivo hemostatic and immuno‐inflammatory profiles of freeze‐dried plasma

et al. 2021

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Background Hemorrhage is a leading cause of preventable death in civilian and military trauma. Freeze‐dried plasma is promising for hemostatic resuscitation in remote prehospital settings, given its potential benefits in reducing blood loss and mortality, long storage at ambient temperatures, high portability, and rapid reconstitution for transfusion in austere environments. Here we assess the ex vivo characteristics of a novel Terumo's freeze‐dried plasma product (TFDP). Study design and methods Rotational thromboelastometry (ROTEM) tests (INTEM, EXTEM, and FIBTEM) were conducted on plasma samples at 37°C with a ROTEM delta‐machine using standard reagents and procedures. The following samples were analyzed: pooled plasma to produce TFDP, TFDP reconstituted, and stored immediately at −80°C, reconstituted TFDP stored at 4°C for 24 h and room temperature (RT) for 4 h before freezing at −80°C. Analysis of plasma concentrations of selected cytokines, chemokines, and vascular molecules was performed using a multiplex immunoassay system. One‐way ANOVA with post hoc tests assessed differences in hemostatic and inflammatory properties. Results No significant differences in ROTEM variables (coagulation time [CT], clot formation time, α‐angle, maximum clot firmness, and lysis index 30) between the TFDP‐producing plasma and reconstituted TFDP samples were observed. Compared to control plasma, reconstituted TFDP stored at 4°C for 24 h or RT for 4 h showed a longer INTEM CT. Levels of immuno‐inflammatory mediators were similar between frozen plasma and TFDP. Conclusions TFDP is equivalent to frozen plasma with respect to global hemostatic and immuno‐inflammatory mediator profiles. Further investigations of TFDP in trauma‐induced coagulopathy models and bleeding patients are warranted.

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