Monday, July 28, 2014
Virginia Commonwealth University Medical Center is conducting a study to evaluate the use of fresh frozen plasma, a component of blood that enables clotting, when emergency services personnel reach a patient rather than when the patient arrives at the hospital.
VCU is one of three academic medical centers in the country that has been selected to participate in this study, funded by a grant from the U.S. Army Medical Research and Materiel Command, Combat Casualty Care Research Program. The principal investigator leading the study at VCU is Bruce Spiess, M.D., professor in the VCU Department of Anesthesiology and researcher with the VCU Reanimation Engineering Science Center, or VCURES.
In more than 95 percent of major trauma cases involving severe bleeding, patients receive blood and plasma products once they are transported to the hospital, usually immediately in the emergency department, to replace lost blood as well as the lost clotting factors.
In the resuscitation of severe trauma, a coagulopathic state, or an inability to clot normally, develops within the first minutes to hours after trauma. Currently, the standard of care by EMS personnel is to give trauma patients saline (salt water) solution intravenously to help replace lost blood and to keep blood pressure up until the patient reaches the hospital.
Saline, however, cannot carry oxygen to the body’s tissues. Fluid resuscitation with traditional fluids, such as saline, appears to worsen the coagulation issue through some very complex mechanisms and leads to further bleeding and complications.
Many studies on soldiers from the Iraq and Afghanistan wars and on patients in trauma centers around the country suggest that the earlier, more vigorous replacement of clotting factors by giving plasma improves survival from massive injuries.
The aim of this study is to evaluate whether patients who receive plasma as soon as possible after suffering a non-head related trauma have reduced bleeding/transfusion and pain, better clinical outcomes and improved survival rates. The study would begin with the patient before arriving at the hospital, either at the scene of the injury or in the ambulance. The study will lay the groundwork for civilian and military improvements in treatment of the most severely injured victims.
VCU was selected by the Army to participate in this study because of its Level I Trauma Center designation and the high number of trauma victims it receives.
“A multidisciplinary team, including clinical researchers, pharmacists, engineers, mathematicians and others, will be involved in this important study. Few institutions in the country have the expertise across the spectrum as found at VCU,” Spiess said.
Persons eligible for this study are at least 18 years old and non-pregnant. Because of the severity of their injuries and loss of blood, these individuals may not be able to provide consent to participate. Federal regulations allow emergency-related research in patients with a life-threatening medical problem in which the best known treatment is unknown and the intervention must be given without delay. Patients or their surrogates will be told about their participation at the earliest opportunity after the event and will be able to provide permission to continue the study. Except for a total of four blood draws, once patients arrive at VCU they will receive no other study interventions –- but would still receive the care they would normally receive if not participating in the study. A patient's participation is expected to last for 30 days after injury.
Individuals who do not wish to participate in this study can request a wristband to wear at all times that will express their wishes not to participate. The study is expected to last through 2016.
For more information about this study and to request an opt-out wristband, contact Judy Katzen, at 804-82-PLASM (804-827-5276) or visit go.vcu.edu/plasma
About VCU and VCU Medical Center
Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 223 degree and certificate programs in the arts, sciences and humanities. Sixty-eight of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. MCV Hospitals and the health sciences schools of Virginia Commonwealth University comprise VCU Medical Center, one of the nation’s leading academic medical centers. For more, see www.vcu.edu.