Spray‐dried plasma: A post‐traumatic blood “bridge” for life‐saving resuscitation

Abstract

Massive bleeding remains a major source of morbidity and mortality worldwide. Recent studies have shed light on the pathophysiology of traumatic‐induced coagulopathy and the central role of endotheliopathy. Transfusion therapy has changed dramatically in the last decade with use of red cells and plasma in a 1:1 ratio. The use of early transfusion increases the likelihood of a favorable outcome. Early intervention‐preferably less than 60 min of injury‐is a major factor in improved survival. Experience with dried plasma products—lyophilized or freeze‐dried—in Europe and South Africa has demonstrated both safety and efficacy. Dry plasma products are not available in the United States but several products are in development. Spray‐dried plasma contains clinically meaningful levels of coagulation activity and in vitro data suggest robust ability to generate thrombus. The decentralized, blood‐center based manufacturing model of spray‐dried plasma offers advantages for availability to meet routine and extraordinary demands.

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

“…Each of these products meets quality standards and has been used with clinical success for the same indications for use as their source plasma or other forms of plasma or pathogen-reduced plasma. The key shortcoming of these approved products, as well as some in development for the US market, lies with their availability, which is due to a dependence on centralized manufacturing [74].…”

“…In addition to lyophilization, dried plasma has been prepared using the spray-drying method and characterized for proteins and coagulation activities [61,74]. The spray-drying method rapidly removes water using a combination of heated, clean dry air, variable plasma flow rates, pressure, and specialized spray nozzles to atomize plasma and rapidly remove the water fraction, down to about 1%.…”

“…In addition, dried plasma has recently been produced using a spray-drying method and a decentralized, blood center-based manufacturing model [74]. As summarized in Table 1 and Figure 3, there are several freeze-and spray-dried plasma products under development [45,[89][90][91][92], such as the following:…”

“…However, the low prevalence of AB blood donors further limits the product's availability [104]. Broader availability of dried plasma appears to be also limited by productspecific, business-related, and regulatory issues [90], and is dependent on centralized manufacturing for currently licensed FDP products [74]. Both Terumo BCT FDP and Velico Medical SDP are manufactured using established regional blood centers.…”

Use of Dried Plasma in Prehospital and Austere Environments

“…A spray-drying device and proprietary bag system (Frontline ODP System) for blood centers to produce spray-dried, single-donor plasma (decentralized model) is being developed by Velico Medical (USA). 16,[21][22][23] A phase I clinical trial has recently been approved for the Frontline ODP System. 24 Terumo BCT (USA) is developing a device for blood centers to make pooled (mini-pools, 10 donors) lyophilized plasma, also using a bag system.…”