Researchers at Loma Linda University Health (LLUH) Level I Trauma Center are participating in an international observational clinical study to determine how partial resuscitative endovascular balloon occlusion of the aorta, or partial REBOA, could increase trauma patients’ chances of survival from non-compressible torso hemorrhage (NCTH) by buying time to treat. This study is funded by the United States Army Medical Research and Development Command (USAMRDC) to fix one of the most important medical challenges on the battlefield and at home - death from NCTH. LLUH was chosen by the USAMRDC to participate in this study along with seven other leading Level I trauma centers across the United States and Canada.
The trauma team at LLUH already performs partial REBOA to help stop a patient’s internal bleeding through a device called pREBOA-PROTM (Prytime Medical Devices, Inc., Boerne, TX). Now the team will participate in the clinical study, called PROMPT (Partial REBOA Outcomes Multicenter ProspecTive) Study, to share prospective data about the use of the device. There are four key endpoints of the PROMPT Study: 1. Time of occlusion, 2. Ischemic markers, 3. Tolerance of reperfusion, 4. Blood pressure.
“The PROMPT study may one day change how sick trauma patients are cared for worldwide,” said Kaushik Mukherjee, MD, MSCI, FACS, trauma medical director and division chief of Acute Care Surgery at Loma Linda University Health.
The PROMPT study will provide the trauma community with in-depth clinical data by enrolling 340 patients in two years across all eight selected centers. LLUH patients who match the inclusion criteria will be automatically enrolled in the study beginning in September 2024.
Loma Linda University Health’s Level 1 Trauma Center cared for 3,300 injured patients in 2023 and has been verified as an Adult and Pediatric Level I trauma center since 2018.
Learn more about Loma Linda University Health’s Level I Trauma Center.
About Loma Linda University Health (LLUH)
Loma Linda University Health includes Loma Linda University's eight professional schools, Loma Linda University Medical Center's six hospitals — including The Dennis and Carol Troesh Medical Campus, which opened in August 2021, housing the new adult hospital and Children’s Hospital expansion — and more than 1,100 faculty physicians located in the Inland Empire of Southern California. Established in 1905, Loma Linda University Health is a global leader in education, research and clinical care. It offers over 100 academic programs and provides quality healthcare to over 40,000 inpatients and 1.5 million outpatients each year. A Seventh-day Adventist organization, Loma Linda University Health is a faith-based health system with a mission "to continue the teaching and healing ministry of Jesus Christ."
ABOUT PRYTIME MEDICAL DEVICES, INC.
The pREBOA-PROTM device is a product of Prytime Medical Inc, The REBOA Company™, a leading innovator and global provider of lifesaving REBOA products. Prytime was selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $6 million awarded through the Medical Technology Enterprise Consortium (MTEC) under Other Transaction Number W81XWH-15-9-0001 .
ABOUT U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND (USAMRDC)
The U.S. Army Medical Research and Development Command is the Army's medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense. https://mrdc.amedd.army.mil/
ABOUT MEDICAL TECHNOLOGY ENTERPRISE CONSORTIUM (MTEC)
The Medical Technology Enterprise Consortium is a 501(c)(3) biomedical technology consortium that is internationally dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians. To find out more about MTEC, visit mtec-sc.org.
Disclaimer: The views expressed in this news release/article are those of the authors and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
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