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Jan Jansen, Ph.D., director of the UAB Center for Injury Science and co-chief investigator of the study.
A new technique used to control severe bleeding in injured patients has been found to increase the risk of death, according to new research from the University of Aberdeen, in Scotland, which was led by University of Alabama at Birmingham trauma surgeon and professor Jan Jansen, Ph.D. Jansen was a surgeon and researcher in Aberdeen before moving to the United States in 2017.
The world’s first clinical trial of Resuscitative Endovascular Balloon Occlusion of the Aorta, also known as REBOA, found that patients treated with REBOA were more likely to die than those who did not undergo REBOA. REBOA was being considered for greater use in the United Kingdom’s National Health Service, and the University of Aberdeen research team had been funded to determine whether it was beneficial or not.
REBOA can be used to control bleeding from serious injuries — such as those seen in car crash victims or people who have fallen from a height — and involves temporarily stopping the blood flow to the lower part of the body until patients can be taken to an operating room.
Life-threatening bleeding in the abdomen or chest usually requires an operation to stop it, and people with such injuries can sometimes bleed to death in the emergency department before they can reach an operating room.
REBOA is a technique whereby a small balloon is introduced through the femoral artery in the groin and then inflated inside the aorta. Although first attempted in 1954, the procedure has been refined and developed over the past decade, and dedicated REBOA devices are now offered by several companies. The aim is to limit blood loss and redirect the remaining blood to the brain and heart. The technique is intended to “buy time,” alongside other life-saving interventions, until the patient can be taken to an operating room, where the bleeding can be stopped for good.
The study published in JAMA on Thursday, Oct. 12, took place in 16 major trauma centers in the U.K., where 90 adult trauma patients took part, and were randomly selected to receive standard care or standard care and REBOA.
Unexpectedly, the trial showed that the use of REBOA increased the risk of death, rather than reduced it. In the standard care group, 42 percent of patients died within 90 days of their injury, compared to 54 percent of participants in the standard care plus REBOA group.
Jansen was the co-chief investigator of the study. He explains that, with bleeding being the most common cause of preventable death after injury, it was hoped that using REBOA in the emergency department would reduce the risk of bleeding to death. But the study found the opposite.
“This may be because REBOA is a challenging and complex procedure to perform, especially in patients who are at imminent risk of dying,” Jansen said. “The trial clearly did not show the expected benefits but is incredibly important because it will prompt clinicians and trauma centers to reevaluate whether they should be using REBOA in emergency departments.”
Jansen says the surprising findings are a clear example of why randomized clinical trials are so important.
“Studies like this, although difficult to execute, evaluate whether an intervention truly makes a difference in the real-life setting,” Jansen said. “Decisions on whether to implement new treatments must be based on high-quality evidence.”