Attenuating the Endotheliopathy of Trauma in Multidomain Operations with Combinations of Freeze-Dried Platelets and Dried Plasma
Abstract
Research objectives and rationale behind proposed work: This proposal addresses the issue of blood product availability in remote environments for bleeding patients. In this proposal, we will explore how dried blood products, namely spray-dried plasma (SDP) and freeze-dried platelets (FDP), two novel blood products, can be utilized to stop bleeding prevent organ failure, leading causes of death in severely injured trauma patients. We plan to measure the therapeutic effects of FDP and SDP in preventing organ failure and stopping bleeding. Dried blood products can be logistically superior, safer, and potentially more efficacious than standard blood products such as fresh-frozen plasma (FFP) and platelets. Sub-Areas to Be Addressed: The Combat Casualty Care Research Program Multi-Domain Lifesaving Trauma Innovations Award areas to be addressed in this proposal include (1) the development of highly innovative novel blood products (SDP and FDP) and (2) the development of “knowledge products” that address new ways, methods, or modifications to existing blood product transfusion practice in trauma. This proposal aligns with Focus Areas 1 and 2. Addressing Focus Area 1 and 2 is our effort to the test logistically feasible, novel blood products – dried plasma in combination with dried platelets – for hemostasis and end organ support. Both products can support the prolonged field care/en route care of wounded warfighters in future multi-domain operations where evacuation may be significantly delayed or unavailable. Both dried plasma and dried platelets are lifesaving, hemostatic, and organ-protective interventions that can be administered in remote and austere settings. This proposal addresses the following sub-areas within all three Focus Areas: (a) prolonged and en route care, (b) battlefield for immediate resuscitation, and (c) stabilization of combat casualties. Desirable characteristics of these products include low weight, low power needs, long shelf life, easy interoperability, ruggedization, and low complexity. Clinical Applications, Benefits, and Risks: The proposal also helps expand our understanding of the ways FDP and SDP can be combined to help treat bleeding and also to treat the secondary consequences of massive blood loss, i.e., lung injury, liver injury, and kidney failure. Hemorrhage remains the leading cause of preventable death in U.S. warfighters, accounting for approximately 80% of combat-related casualties. Understanding how SDP and FDP, alone and in combination, can be optimally used to treat hemorrhage and trauma could allow for development of clinical protocols and methods to reduce organ failure and death. This research is directly applicable to evaluating the efficacy and safety of these novel products currently under development for bleeding trauma patients. Furthermore, this proposal aims to optimize the resuscitation paradigms and ratios of SDP to FDP in injured bleeding patients. The information gained from these studies can ultimately assist in developing treatment protocols designed to save lives in both military and civilian settings and decrease the long-term effects of injury. Projected Timeline to Achieve the Expected Patient-Related Outcome: The main goal of this proposal is to develop the knowledge necessary to best utilize two novel blood products (SDP and FDP) in combination to treat wounded military and civilian personnel in areas with limited blood product availability. We anticipate that the timeline to achieve the expected patient outcomes will be 4-5 years. Since both products are in development by commercial market developers and both are either in clinical trials or close to clinical trials in humans, we anticipate this timeline is a reasonable estimate to implement combination dried blood product use in patients. Benefit to Service Members and Civilian Personnel: This proposal aims to test the novel utilization of these hemostatic products in combination
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Mar 10, 2021
- Source ID
- W81XWH2010824
Entities
People
- Shibani Pati
Organizations
- United States Army
- University of California, San Francisco