VCU Study to Evaluate Early Intervention Using Plasma in Trauma Patients

By Frances Dumenci

Virginia Commonwealth University Medical Center is proposing a research study to evaluate the use of fresh frozen plasma, a component of our blood that has substances that enable clotting, administered by emergency services (EMS) personnel before the patient reaches 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 Material 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 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 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 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 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,” said Spiess.

Persons eligible for this study are 18 to 80 years old and non-pregnant. Because of the severity of their injuries and the shock state they may be in, these individuals may not be able to provide consent to participate. Permission from the patient or their surrogate will be attempted as early as it is feasible. 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. Once approved by the VCU Institutional Review Board, the study is expected to last for three years.

For more information about this study and to request an opt-out wristband, call 804-82-PLASMA (804-827-5276), email plasmastudy@vcu.edu or visit go.vcu.edu/plasma.