Prehospital Kcentra for Trauma Patients with Hemorrhagic Shock
Abstract
When a person suffers an injury that causes hemorrhage, the body’s reaction is to initiate clotting to stop the bleeding. Paradoxically, severe hemorrhage can cause the opposite response, resulting in condition called the acute coagulopathy of trauma (ACT). This results in a suppression of blood clotting pathways, leading to additional bleeding. Treating coagulopathy is difficult due to the complications that arise from hemorrhage in addition to the initial injury. Although the medical community has developed a process or protocol for treating traumatic injury and hemorrhage, the percentage of deaths due to hemorrhage and its associated shock remains high and many deaths from bleeding may be preventable. Early treatment is critical to improve outcomes in trauma patients with bleeding. Treatment in the field and austere environments becomes more problematic due to logistical issues such as storage conditions, portability, weight, availability, and administration. While whole blood is the optimal resuscitation fluid, it is difficult to carry and store, especially in battlefield conditions and must be refrigerated. Whole blood can be separated into red blood cells, platelets, and plasma and administered in an effort to alleviate the hemorrhage, but each component carries similar issues for storage and transportation. What is needed is a lightweight, temperature neutral, easily transported pharmaceutical that shows immediate benefit for hemorrhage in the field. We believe Kcentra, a 4-Factor Prothrombin Complex Concentrate (4FPCC) serves this purpose well. It is stored in powder form a room temperature for a prolonged period of time and can be rapidly dissolved in fluid when it is needed. A single dose of 4FPCC contains the equivalent amount of coagulation factors as several units of plasma. Prothrombin concentrates have been recognized by the World Health Organization as essential medicine that has shown benefit for patients suffering from hemorrhage due to vitamin K antagonists. 4FPCCs are routinely used in the United States to rapidly reverse the effects of blood thinners, and they have been proven to be very safe in this setting. However, what is not known is whether the benefits of Kcentra to treat vitamin K antagonist hemorrhage can be translated to patients who are bleeding after trauma and who are not on blood thinners. In line with the FY21 PRMRP topic area of hemorrhage control, we propose to conduct a multi-center trial to determine if prehospital administration of 4FPCC confers a survival benefit in patients who suffer from severe traumatic hemorrhage.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210601
Entities
People
- Martin Schreiber
Organizations
- Oregon Health & Science University
- United States Army