In a CNTR-managed clinical trial that’s now beginning to enroll patients, Leopoldo Cancio, MD, burn surgeon and the Director of the U.S. Army Burn Center, is examining the use of INTERCEPT-treated pathogen-reduced plasma (IPRP) in the resuscitation of burned patients.
The study, called PROpOLIS (Plasma Resuscitation withOut Lung Injury), uses IPRP, an FDA-approved blood component that has undergone treatment to reduce the risk of transfusion-transmitted infection. IPRP is prepared with technology developed by Cerus Corporation, a global blood products company based in Concord, CA. When IPRP is administered as part of the resuscitation plan in the initial 24 hours of treatment, it may reduce the need for large amounts of intravenous fluids by improving blood vessel integrity and reduce the risk of organ damage.
“A reduction in the amount of fluid administered to burn patients should decrease the potential for lung injury, minimize days in the hospital and improve chances for survival,” explained Dr. Cancio, the study principal investigator. While patients with extensive burns require IV fluids, too much can lead to swelling of the tissues that can cause other complications.
As the coordinating center for the multi-institutional study, CNTR is responsible for end-to-end study management across five clinical sites and two laboratories, involving all policy and procedure, training, and human subject protection activities. The clinical sites are the U.S. Army Burn Center at Brooke Army Medical Center, the University of Alabama at Birmingham, Vanderbilt Regional Burn Center in Nashville, the University of Washington Regional Burn Center at Harborview Medical Center, and the University of Texas Southwestern Parkland Burn Center. Laboratory analysis sites are the University of Maryland at Baltimore, and Cerus Corporation. The University of Washington serves as the Data Coordinating Center.
Cerus supplies vital technologies and systems for production of pathogen inactivated blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. As a partner in this study, Cerus is coordinating the production of IPRP processed in FDA licensed blood centers.
“We are proud to partner with the CNTR on this important study in patients suffering from burns and requiring resuscitation,” said Dr. Laurence Corash, Cerus’ chief scientific officer and co-founder. “Transfusion of blood components in a timely manner is essential for seriously injured patients. Cerus is focused on developing innovations in blood safety and availability. In doing so, treating physicians are better able to address challenges in burn patients as well as other patients requiring resuscitative measures, such as in trauma and surgery.”
This study will be conducted over three years. It is registered as a clinical trial at clinicaltrials.gov; Identifier: NCT04681638. This work is supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through Defense Medical Research and Development Program, Joint Program Committee 6 (JPC-6)/CCCRP Multi-Domain Lifesaving Trauma Innovations (MuLTI) Award under Award No. W81XWH2020032.