Plasma Resuscitation Without Lung Injury (PROPOLIS)
Leopold Cancio, MD
The Plasma Resuscitation Without Lung Injury (PROPOLIS) study will evaluate pathogen-reduced plasma for the resuscitation of patients with shock secondary to extensive burns. PROPOLIS received the Multi-domain Lifesaving Trauma Innovations (MULTI) Award from the Defense Medical Research and Development Program (DMRDP). The study directly attends to two focus areas of high relevance to the current and future battlefield, as well as for civilian trauma care: Prolonged & En Route Care and Battlefield Resuscitation for Immediate Stabilization of Combat Casualties.
“The pathophysiology of burn shock has been fairly well defined, but effective intervention strategies are mainly limited to various intravenous fluid regimens,” explained Dr. Cancio, Director of the U.S. Army Burn Center at the Institute for Surgical Research. “Too often, serious consequences result from over-resuscitation, such as abdominal compartment syndrome and acute respiratory distress syndrome.” The benefits of reduced resuscitation volume include a reduction in the risk of Acute Respiratory Distress Syndrome (ARDS), a common and frequently lethal complication in burn patients, as well as several other serious complications.
Specifically, PROPOLIS is a prospective, randomized, controlled, multicenter trial of pathogen-reduced plasma vs. a standard-of-care therapy based on lactated Ringer’s solution, for the resuscitation of patients with acute burns > 20% of the total body surface area. The study will be conducted at five centers (U.S. Army Institute of Surgical Research,Vanderbilt University, Harborview Medical Center at University of Washington, Sunnybrook Research Institute in Toronto, and University of Alabama).
Investigation into whether endothelial injury can be ameliorated by a change in burn resuscitation therapy from a crystalloid-based strategy to the incorporation of pathogen-reduced plasma early after injury will be conducted by Rosemary Kozar, co-Director for the Shock Trauma Anesthesia Research (STAR) Center at The R Adams Cowley Shock Trauma Center and the University of Maryland School of Medicine.
“This clinical trial illustrates the power of collaboration between trauma and burn researchers,” added Dr. Nicole Gibran, study co-investigator and Chair in Restorative Burn Surgery at Harborview Medical Center, and a Board Member of CNTR’s predecessor organization, the National Trauma Institute. “Having the American Burn Association (ABA) join CNTR as a core member reinforces the reality that burn injuries represent one type of trauma and must be included in national trauma research, prevention and advocacy efforts if we are to make progress in achieving our national goal of Zero Preventable Deaths and Disability.”
Cerus Corporation will supply the participating sites with the INTERCEPT plasma for the study.