The University of Maryland Medical Center Program in Trauma Research seeks to continue operating a Core Clinical Center in the NHLBI Transfusion Medicine and Hemostasis Clinical Research Network. We will work through the Network program to develop evidence through clinical trials concerning the safety and effectiveness of blood products, drugs, and devices for hemostasis and hemorrhage control. We have developed a highly qualified team to investigate these products. 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 represent about 15% of the national total. Hemorrhage is the most frequent cause of preventable trauma death. The clinical trials we proposed in the initial period addressed the use of rVlla and the dry fibrin sealant dressing for controlling major hemorrhage. The rVlla trial we proposed was taken over by the manufacturer and conducted in eight other countries when the FDA placed the trial on hold in the US for more than 3 years. The dry fibrin sealant dressing development program collapsed when the American Red Cross got out of the plasma business. Nevertheless, ideas and evidence developed in attempting to establish these trials have proven lifesaving in both civilian and military casualty care. The social forces that make the University of Maryland Medical Center an outstanding site to conduct trauma studies work against its participation in some Network studies, as in the winter and spring of 2006 when 14 patients transferred to the Medical Center with acute leukemia and otherwise eligible for the Platelet Dose Study could not be approached because they did not speak English. Also, a change in Maryland state law has made it impossible to enroll children in some studies. We continue to develop ideas, such as the supplementation of massive transfusion with cryoprecipitate which can be developed as randomized controlled trials and to enroll patients in the ongoing trials. Reducing death from acute hemorrhage in trauma care will be a major step forward in reducing overall trauma mortality.
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