Lyophilized plasma attenuates vascular permeability, inflammation and lung injury in hemorrhagic shock

Pati, Shibani; Peng, Zhanglong; Wataha, Katherine; Miyazawa, Byron; Potter, Daniel R.; Kozar, Rosemary A.

doi:10.1371/journal.pone.0192363

Cited by 50 publications

(74 citation statements)

References 41 publications

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“…Lyophilized plasma (LP) demonstrated similar effects as FFP, both in vitro and in vivo, on reducing endothelial cell permeability, increasing trans-endothelial resistance, decreasing leukocyte-endothelial binding, and preserving adherens junctions. In an in vitro mouse model of hemorrhagic shock, LP and FFP both equally reduced pulmonary injury, inflammation, and vascular permeability [71]. Spray-dried plasma (SDP) also reduced vascular permeability and other indicators of endothelial damage as well as FFP [72].…”

Section: Studies In Animal Models Of Shockmentioning

confidence: 99%

Dried Plasma

Zaza¹,

Kalkwarf²,

Holcomb³

2019

Damage Control Resuscitation

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Section: Studies In Animal Models Of Shockmentioning

confidence: 99%

Dried Plasma

Zaza¹,

Kalkwarf²,

Holcomb³

2019

Damage Control Resuscitation

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“…Implementation of dried plasma products is being driven through several mechanisms. Development of a foundation of research based on preclinical investigations of dried plasma in models of polytrauma and hemorrhagic shock, traumatic brain injury, and models further elucidating the mechanism of endotheliopathy of trauma support the use of plasma and dried plasma for trauma. The breadth of these investigations reflects an appreciation that the protective mode of action of plasma may be attributable to a broader effect of plasma as a balanced component for a range of abnormalities associated with trauma and shock .…”

Section: Implementation and Reimbursement Issuesmentioning

confidence: 99%

Challenges to producing novel therapies – dried plasma for use in trauma and critical care

Buckley

Gonzales²

2019

Transfusion

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C hallenges to modern dried plasma development exist at multiple points along the product development cycle and include the regulatory pathway, funding, logistics, implementation, and commercial viability. The regulatory path for these products requires a clinical development pathway similar to a drug that entails longer timelines and substantial funding. US efforts to develop a dried plasma product have been military driven in response to a demand arising from the Operation Iraqi Freedom and Operation Enduring Freedom conflicts. A memorandum of understanding has existed between the Department of Defense (DoD) and the Food and Drug Administration (FDA) since 1974 for the purpose of expediting review of special DoD requirements to meet national defense considerations and set the requirement for clinical testing through submission of an investigational new drug (IND) or investigational device exemption (IDE) application. 1 Modern development of a US-based dried plasma product has been under way since the early 2000s, challenging expectations for an expeditious process. A new initiative between the DoD and FDA was announced in January 2018, with the goal of streamlining the product development path. This initiative, coupled with continued clinical investigation, will result in US dried plasma products being available on the market soon, and may demonstrate that these efforts have the potential to hasten future product development pathways. BRIEF HISTORY OF DRIED PLASMADemand for freeze-dried plasma (FDP) production arose from military need for a resuscitation fluid to treat hemorrhagic shock due to blood loss resulting from battlefield injuries. 2 Widespread use of dried plasma began in the 1940s by US and British military forces during World War II for the primary indication of management of shock. 2 Due to the large quantities of plasma needed, freeze-dried (lyophilized) plasma was produced by several biologic manufacturers by pooling thousands of units that were dispensed into glass bottles, freeze dried, stoppered upon completion of drying, and then packaged in tin cans to resist breakage. Location of the manufacturers was selected based on proximity to plasma collection centers to streamline production. 2 The French similarly began manufacture of FDP to support military use during the Indochine War. 3 US production efforts were eventually discontinued due to contamination of the large plasma pools with hepatitis B virus (HBV), with reported rates of transmission of hepatitis B virus during the Korean War of up to 21%. 4 Pooled lyophilized plasma was formally withdrawn from use by the FDA in 1968 because of known risk of pathogen transmission. 5 Concerns regarding transmission of human immunodeficiency virus suspended further development efforts in the 1980s.Production was reinitiated by the French in the early 1990s during the Gulf War to support military operations. 3 The German Red Cross Blood Service West also began manufacturing in the 1990s a lyophilized pooled product that used the solvent/detergent metho...

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“…This suggests that if prehospital FFP provides benefit, it is unlikely that this is through the substitution of coagulation factors. Other modes of FFP benefit include protecting the endothelial glycocalyx and reducing vascular permeability and inflammation …”

Section: Comparison Of the Pamper And Combat Trialsmentioning

confidence: 99%

“…Other modes of FFP benefit include protecting the endothelial glycocalyx and reducing vascular permeability and inflammation. 5,6 We compared the PAMPer and COMBAT trials looking for differences in their design and conduct to shed light on the true effect of FFP, if any (Table 1). Of course, the simplest explanation for the difference in results could well be a combination of chance and low power for the COMBAT study, due to low event rate and small sample size.…”

mentioning

confidence: 99%