OhioHealth Grant Medical Center’s Trauma Program Joins International Clinical Trial
The Level I Trauma Center at OhioHealth Grant Medical Center is participating in an international clinical trial to study how a device may improve chances of survival for trauma patients. Grant Medical Center will be just one of just eight trauma centers worldwide to participate.
In the spring of 2021, Grant’s trauma team became the first in the world to use Prytime Medical Devices’ pREBOA-PRO™, a partial catheter that is used to stop blood loss in the most severe trauma cases. OhioHealth has been using the original REBOA (an abbreviation for Resuscitative Endovascular Balloon Occlusion of the Aorta) since 2017. The updated version improves on the original, with a capability to work like a dimmer switch, allowing blood flow to continue to go to the heart, brain and lungs, helping to prevent future medical issues.
Now, over the next 24 months, Grant will participate in the PROMPT (Partial REBOA Outcomes Multicenter ProspecTive) study, sharing data about the use of the device.
“In our years of using the device, we have seen it make a big impact in helping to stop bleeding and stabilize our trauma patients,” said Urmil Pandya, MD, medical director of trauma at Grant. “The ability to keep good blood flow to the brain, heart and lungs while we work to save the lives of our patients has been vital. We are looking forward to sharing our data to see how this can help impact the future of trauma care worldwide.”
The study will look at results from 340 patients over two years among the eight participating Level I trauma centers. Patients who match the criteria of the study will automatically be enrolled. The device may not be appropriate for all patients. The pREBOA-PRO™ device has been approved by the FDA.
The nearly $6 million study is being funded through the U.S. Department of Defense awarded through the Medical Technology Enterprise Consortium.
Grant is the busiest adult Level I Trauma Center in the state of Ohio. According to the Vizient Mortality Index, Grant ranks No. 1 out of seven participating Level I trauma centers in Ohio – meaning that if someone in Ohio experiences a traumatic event, their chances of survival are better at Grant than anywhere else.
Based in Columbus, Ohio, OhioHealth is a nationally recognized, not-for-profit, charitable, healthcare outreach of the United Methodist Church. Serving its communities since 1891, OhioHealth is a family of 35,000 associates, physicians and volunteers, and a network of 14 hospitals, three joint-venture hospitals, one managed-affiliate hospital, 200+ ambulatory sites and other health services spanning a 50-county area. It has been recognized by FORTUNE as one of the “100 Best Companies to Work For” 15 times since 2007. For more information, visit ohiohealth.com.
About The PROMPT Study
The Partial REBOA Outcomes Multicenter ProspecTive (PROMPT) Study is the first large-scale multicenter prospective study for Partial REBOA. Most studies on Partial REBOA to date have been animal studies, small human enrollment studies, and/or retrospective. The PROMPT Study will enroll 340 subjects over a 24-month period. There are four key endpoints for the study: 1. Time of occlusion 2. Ischemic markers 3. Tolerance to reperfusion 4. Blood product use. The lead site will be Vanderbilt University Medical Center and will begin enrolling soon. Additional sites will be announced soon.
About Prytime Medical Devices, Inc.
Prytime Medical™ Devices, Inc. is an innovative medical device company that designs, develops, and commercializes minimally invasive solutions for hemorrhage control. The underlying intellectual property for REBOA was conceived based on lessons learned in war. Our latest innovations, the industry leading ER-REBOA PLUS™, and the innovative pREBOA-PRO™ Partial REBOA Catheter, enable truncal hemorrhage control with more controlled resuscitation in a much wider range of clinical scenarios. pREBOA-PRO™ is the first FDA-cleared REBOA catheter designed specifically for True Partial REBOA™. More information can be found at http://www.PrytimeMedical.com
About U.S. Army Medical Research and Development Command
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/ [urldefense.us]
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.