Dried plasma: An urgent priority for trauma readiness

As the US military pivots from years of low-intensity counterinsurgency operations to preparation for large-scale combat operations against a near-peer competitor, the realities of providing medical care to thousands of casualties are sobering.1 Evidence collected during recent conflicts reinforces that damage-control resuscitation and early hemorrhage control are crucial to survival for patients with severe injuries. Numerous studies continue to demonstrate the criticality of early lifesaving interventions and the impact of timely and appropriate resuscitation with blood products.2–12 Minutes matter when it comes to transfusion and so does the product transfused: whole blood and early plasma are lifesaving interventions that improve survival rates for patients with traumatic injuries.8,9 Future conflicts are likely to include widespread use of artillery and rockets delivering incendiary and thermobaric munitions, resulting in increased numbers of burn casualties, further increasing requirements for plasma.13,14 Globally, health care systems have sized their blood collection and processing capabilities and capacity to meet peacetime requirements. To meet projected requirements for a future conflict, the United States and its allies and partners should enhance efforts to develop lifesaving blood product solutions and resuscitative adjuncts. The Department of Defense (DoD) is currently developing systems for early blood transfusion proximate to the point of injury using cold-stored low titer O whole blood, but there are numerous logistics challenges to providing standard blood products in austere locations and supplies will certainly be limited, particularly in the early and most intense phases of conflict. In addition, DoD is expanding the ability of deployed units to use “walking blood banks,” built on an emergency donor panel that would include most deployed personnel. However, walking blood banks donors are not always available when needed and in the required quantity. Also, donors can only safely donate blood about every 56 days under normal noncombat conditions. Even with these initiatives, DoD and its allies and partners should develop additional mitigation measures to increase the ability to provide blood products when and where needed. Given the benefits of early plasma resuscitation8,9 and the current state of technology, dried plasma is the most proximate and feasible solution. We must accelerate efforts for the development and large-scale procurement of a dried plasma product for use by all deployed forces as a critical capability to ensure readiness to support future conflicts. Dried plasma is not a new technology, nor is its use as a bridge to whole blood resuscitation a novel approach.13 Initially developed by Max Strumia in 1938 at Bryn Mawr, millions of units of dried plasma were produced in the United States and in other countries for shipment to frontline units during World War II.15 In the postwar years, given the decreased demand for blood products and the recognition of the risk of viral hepatitis from pooled plasma transfusion, most efforts, including in the United States, were suspended. Both France and Germany sustained their programs after incorporating changes in manufacturing to reduce the risk of transmitting infectious diseases. Advances in bloodborne pathogen testing, pathogen reducing technology, and the need for shelf-stable blood products have resulted in a reassessment of the importance of dried plasma. Currently, the French Military Medical Service, the German Red Cross, and the National Bioproducts Institute of South Africa all manufacture dried plasma products with regulatory approval. In addition, Octapharma AG of Switzerland recently received regulatory approval in Europe for its dried plasma product. These products are used in civilian and military emergency medical systems in several countries including Canada, the Czech Republic, France, Germany, Israel, Norway, and the United Kingdom. Since 2011, US Special Operations Forces have also used French freeze-dried plasma for resuscitation at the point of injury, initially through the Food and Drug Administration's Expanded Access program and more recently under an Emergency Use Authorization.16,17 However, there currently is no fully approved dried plasma product for the US market, although several remain under development. In addition, dried plasma projects are underway in several European nations, Canada, and Australia. These include both centrally manufactured freeze-dried plasma products and distributed manufacturing systems usable at blood collection centers. Four use cases for dried plasma are proposed. 1. Immediate resuscitation at the point of injury, until other blood products are available; 2. Initial resuscitation along with red blood cells and other components such as cold-stored platelets; 3. Replacement for liquid or frozen plasma throughout the prehospital and early/acute in-hospital continuum of care; 4. Initial resuscitation of burn shock.13,14 As an immediate resuscitation capability for the battlefield that can be safely stored at room temperature, dried plasma should be available along the entire continuum of combat casualty care. This means that the product should be issued to all field medics and corpsmen, as well as carried on all en route care platforms, including ground ambulances. Given the challenges of resupply in a contested environment, adequate stockpiles of product must be strategically prepositioned within theater and distributed forward to operating units to facilitate “last mile” delivery. To this end, we recommend that in-theater liquid and frozen plasma be replaced with dried plasma as pioneered by the French military,18–21 particularly between point of injury and forward surgical units. Further modeling and analysis of which casualties are most likely to benefit from dried plasma, who will be trained to administer it, and related logistical considerations will help clarify how much dried plasma will be needed in future conflicts and how increased utilization of dried plasma will decrease cold chain storage requirements in the forward operating environment. More than 10 million units of dried plasma were produced in the United States and shipped overseas during World War II. These numbers are useful in appreciating the magnitude of scale that will be required during a large-scale conflict. The Joint Trauma System, in cooperation with the Armed Service Blood Program and the Office of the Joint Staff Surgeon, recently reassessed blood planning factors. Based upon historical experience from past conflicts and DoD Trauma Registry data, casualties who require transfusion need an average of 8 U of whole blood (or whole blood equivalents from components). As additional data from the conflict in Ukraine and/or the Joint Trauma System and Armed Service Blood Program become available, these planning factors can be adjusted to reflect point of need resuscitation. We suggest an initial planning factor of at least 2 U of dried plasma product for each of these casualties for immediate resuscitation and bridging to other blood products. As we prepare for potential future conflicts or large-scale natural disasters, we must accelerate development activities that will yield both centrally manufactured dried plasma products that can be rapidly procured, as well as distributed manufacturing capabilities that can be leveraged by the Armed Services Blood Program and civilian partners to provide surge capacity. Action today will better prepare our health care system to successfully resuscitate future casualties with survivable injuries.

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