Freeze-dried plasma for major trauma – Systematic review and meta-analysis

Mok, Garrick; Hoang, Richard; Khan, Montaha Wajid; Pannell, Dylan; Peng, Henry T.; Tien, Homer; Nathens, Avery B.; Callum, Jeannie; Karkouti, Keyvan; Beckett, Andrew; Luz, Luís Teodoro da

doi:10.1097/ta.0000000000003012

Cited by 29 publications

(29 citation statements)

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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%

“…Freeze dried or lyophilized whole plasma and plasma fractions provide a promising alternative to FP for remote prehospital resuscitation of traumatic shock and coagulopathy; FDP is easy to store at ambient temperatures, transport, and reconstitutes quickly and efficiently, resulting in a rapid time‐to‐transfusion 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.…”

Section: Discussionmentioning

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 .…”

Section: Introductionmentioning

confidence: 99%

“…33,46,47 Moreover, recent systematic reviews and metaanalysis 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, 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.…”

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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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“…The overall safety and efficacy of FDP may be equivalent to allogenic blood products based largely on observational studies; however, there are no data from larger, randomized controlled trials comparing FDP with FFP to confirm this. Furthermore, the effects of FDP on host auto-inflammatory reactions, if any, are unknown [ 155 ]. Finally, concerns regarding disease transmission, including hepatitis, with the use of pooled FDP, led to the cessation of large-scale production [ 156 ].…”

Section: Management Of the Polytrauma Victimmentioning

confidence: 99%

The Pathophysiology and Management of Hemorrhagic Shock in the Polytrauma Patient

Fecher

Stimpson

Ferrigno

et al. 2021

JCM

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The recognition and management of life-threatening hemorrhage in the polytrauma patient poses several challenges to prehospital rescue personnel and hospital providers. First, identification of acute blood loss and the magnitude of lost volume after torso injury may not be readily apparent in the field. Because of the expression of highly effective physiological mechanisms that compensate for a sudden decrease in circulatory volume, a polytrauma patient with a significant blood loss may appear normal during examination by first responders. Consequently, for every polytrauma victim with a significant mechanism of injury we assume substantial blood loss has occurred and life-threatening hemorrhage is progressing until we can prove the contrary. Second, a decision to begin damage control resuscitation (DCR), a costly, highly complex, and potentially dangerous intervention must often be reached with little time and without sufficient clinical information about the intended recipient. Whether to begin DCR in the prehospital phase remains controversial. Furthermore, DCR executed imperfectly has the potential to worsen serious derangements including acidosis, coagulopathy, and profound homeostatic imbalances that DCR is designed to correct. Additionally, transfusion of large amounts of homologous blood during DCR potentially disrupts immune and inflammatory systems, which may induce severe systemic autoinflammatory disease in the aftermath of DCR. Third, controversy remains over the composition of components that are transfused during DCR. For practical reasons, unmatched liquid plasma or freeze-dried plasma is transfused now more commonly than ABO-matched fresh frozen plasma. Low-titer type O whole blood may prove safer than red cell components, although maintaining an inventory of whole blood for possible massive transfusion during DCR creates significant challenges for blood banks. Lastly, as the primary principle of management of life-threatening hemorrhage is surgical or angiographic control of bleeding, DCR must not eclipse these definitive interventions.

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Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock

Jost

Lemoine

et al. 2022

JAMA Netw Open

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Key Points Question Does prehospital transfusion of lyophilized plasma result in a lower incidence of trauma-induced coagulopathy at hospital admission compared with standard care with normal saline infusion in patients at risk for hemorrhagic shock after trauma? Findings This multicenter randomized clinical trial included 150 patients with trauma who were treated in a prehospital setting. Median international normalized ratio at hospital admission, massive transfusion rate, 30-day survival, and adverse events did not significantly differ between lyophilized plasma transfusion and standard care. Meaning These findings suggest that prehospital lyophilized plasma transfusion is a feasible and safe procedure for patients who are at risk for hemorrhagic shock, although there is a lack of evidence regarding its ability to prevent trauma-induced coagulopathy.

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Freeze-dried plasma for major trauma – Systematic review and meta-analysis

Abstract: Supplemental digital content is available in the text.

Cited by 29 publications

References 52 publications

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

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

The Pathophysiology and Management of Hemorrhagic Shock in the Polytrauma Patient

Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock

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