Acute care surgeons at Vanderbilt University Medical Center are leading a two-year, multicenter observational study of a minimally invasive technique to control life-threatening blood loss by inserting a balloon inside the aorta to restrict blood flow below the heart.
The Partial REBOA Outcomes Multicenter Prospective Trial (PROMPT) was selected by the U.S. Army Medical Research and Development Command (USAMRDC) to receive nearly $6 million in funding from the U.S. Department of Defense grant awarded through the Medical Technology Enterprise Consortium (MTEC).
The study examines clinical outcomes when using a procedure called partial resuscitative endovascular balloon occlusion of the aorta (REBOA) to control hemorrhage and to better define the safest and most effective way to perform the procedure.
“We believe from our experience with the device that it clearly has benefits, but we want to fine-tune this procedure so we can provide the maximum benefit for the greatest number of patients,” said co-principal investigator Bradley Dennis, MD, associate professor of Surgery and medical director of VUMC’s Trauma Intensive Care Unit. “Doing this now, in a controlled fashion with a limited number of trauma centers, will help us standardize partial REBOA use and identify the best practices so we can then help spread that information to the rest of the country.”
Hemorrhagic shock, when severe blood loss leads to inadequate delivery of oxygen to the body’s cells, is a leading cause of death following a traumatic injury. And serious injuries to non-compressible areas of the body such as the torso and abdomen are a clinical challenge due to a lack of effective ways to control bleeding without causing significant harm to the body.
The first documented use of a balloon — a Foley catheter — placed inside the aorta to stem bleeding was during the Korean War in 1954. The idea gained adoption by civilian medical centers in 2017 when a REBOA device was approved by the Food and Drug Administration. VUMC trauma surgeons began using the devices that same year. The technique has been used for approximately 150 trauma patients who met the Medical Center’s criteria for the procedure.
Co-principal investigator Bradley Dennis, MD, associate professor of Surgery and medical director of VUMC’s Trauma Intensive Care Unit
Endovascular hemorrhage control (EHC) devices and minimally invasive techniques such as REBOA are now in use at trauma centers throughout the world. The newest version of the device allows partial blood flow to the body in a controlled manner. This is expected to reduce harm and give medical teams more time to surgically stop bleeding.
Several North American trauma centers that were early adopters of REBOA technology, including VUMC, are now using the partial REBOA and joining the observational study being led by the Medical Center’s Acute Care Surgery team.
REBOA involves feeding a small catheter with a balloon into the femoral artery and upward to sit inside the aorta, the body’s largest artery. The inflated balloon restricts blood flow below the aorta and stabilizes blood pressure, so life is sustained while repairs are made, and the original source of bleeding is addressed.
At VUMC, REBOA has been used largely for blunt trauma injuries, often the result of motor vehicle crashes. An example is a severe pelvic fracture where a high volume of blood can be lost rapidly. REBOA has also proven to be invaluable in other circumstances in the operating room.
“If surgeons are doing a procedure with a high risk for hemorrhaging, we can put the catheter in and not inflate the balloon,” said co-principal investigator Stephen Gondek, MD, MPH, assistant professor of Surgery. “But if something goes wrong, it takes three seconds to inflate it and temporarily stop the blood flow.
While REBOA has proven effective in stemming blood loss, the reduction in blood flow — especially if that flow is halted for longer periods of time — can result in ischemia-reperfusion injuries or tissue damage that occurs when the blood supply returns to the body.
“The most common complication of REBOA is acute kidney injury or AKI,” said Dennis. “Up to 40% of people who survive hemorrhagic shock who received REBOA can have AKI. While AKI is one of those problems we don’t necessarily look forward to, having that problem means the person lived.”