Trauma is the most frequent cause of death of Americans under the age of 35. Trauma is responsible for eight out of ten deaths in adolescents and young adults ages 15-24. Trauma from motor vehicle crashes, penetrating injuries, and falls are responsible for 93,000 deaths each year in the United States. Of the injured admitted to hospitals, 250,000 receive blood transfusions. Annually, trauma patients in the U.S. receive almost 2,000,000 units of red blood cells, which represents about 18% of the national total. Hemorrhage is the most frequent cause of trauma death. It is the predominant cause of deaths from trauma in the pre-hospital setting, a major cause of death in Emergency Departments, and the major cause of death during emergency surgery. Many deaths from acute hemorrhage are preventable. Autopsy series from civilian and military settings indicate that 10 to 20% of deaths from hemorrhage are potentially preventable with better techniques for hemorrhage control. Examples of commonly fatal injuries due to hemorrhage that are difficult to control by traditional techniques include high-grade liver injuries and open ring pelvic fractures. There are, however, several new drugs and biologics recently developed to control acute hemorrhage that hold promise of reducing death from hemorrhagic shock. These drugs and devices require clinical testing in critically injured trauma patients. The University of Maryland Medical Center Program in Trauma Research seeks to build a Core Clinical Center in the proposed NHLBI Transfusion Medicine and Hemostasis Clinical Research Network to advance the clinical safety and efficacy testing of new drugs and devices to reduce mortality from acute hemorrhage in trauma. We have assembled a highly qualified team to Investigate these new drugs and devices. Two clinical trials are proposed. The first trial is to determine if rFVIla can reduce mortality and RBC use in trauma patients with acute hemorrhage, receiving 10 or more units of RBCs. The second trial is to determine the safety and efficacy of the Dry Fibrin Sealant Dressing to control hemorrhage and reduce mortality in trauma patients with severe (AAST Grade 4 & 5) liver injury. These trials represent the best available scientific opportunity to reduce the high mortality associated with massive hemorrhage trauma care. Reducing death from acute hemorrhage in trauma care will be a major step forward in reducing overall trauma mortality.
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