The Hyperbaric Medicine Center at the Nebraska Medical Center is one of 11 units around the nation to take part in a new multicenter phase II clinical trial that is aimed at reducing neurological damage in persons suffering from traumatic brain injuries.
The Hyperbaric Oxygen Brain Injury Treatment Trial (HOBIT) is designed to determine whether hyperoxygen therapy will help reduce brain injury in people who have suffered severe blunt force trauma. Hyperbaric oxygen is the delivery of pure oxygen at higher-than-normal pressure in an enclosed chamber.
The trial is supported and sponsored by the SIREN-NETT (Strategies to Innovate Emergency Care Clinical Trials) Network, which is funded by the National Institutes of Neurological Disorders and Stroke.
"We are anticipating a successful outcome, based on earlier studies that reported impressive improvements in constricting blood flow using hyperbaric oxygen, which decreases the swelling on the brain and lessens the secondary trauma the patient experiences from it," said Jeffrey Cooper, MD, director of hyperbaric medicine for Nebraska Medicine and associate professor of emergency medicine at UNMC.
Dr. Cooper said patients with traumatic brain injuries often suffer a secondary injury due to the way the body responds to the initial trauma with swelling on the brain.
"That inflammation causes direct tissue destruction and further compromises blood flow to the brain causing more brain cell death," he said.
Patients then suffer neurological defects for the remainder of their lives that impact intellect, memory, motor function and cause emotional problems.
"The hope is that through the HOBIT trial, we learn better treatment methods using hyperbaric oxygen that decreases or prevents secondary trauma and allows the brain the time it needs to heal without further complications," Dr. Cooper said.
The only caveat to the study is the timing.
Patients who will take part in the trial will need to be enrolled within eight hours after coming into the emergency room, Dr. Cooper said. And it will need to be a legally authorized representative who will be the person consenting for them to do so, as the patients will be in a drug-induced coma because of their brain injury.
Eligible participants must range in age from 16 to 65.
To make a clinical trial like this happen takes a lot of coordination and cooperation, Dr. Cooper said.
His coinvestigators include: Daniel Surdell, MD, a professor of neurosurgery at UNMC; Brett Waibel, MD, an associate professor in the department of surgery at UNMC; and Erin Etoll, MD, an assistant professor and critical care anesthesiologist at UNMC.
"It has taken a lot to put this together," Dr. Cooper said. "We’ve had tremendous support from the vice chancellor for research and the ER department, trauma, neurosurgery, anesthesiology, respiratory therapy and surgical intensive care unit. It’s truly a multidisciplinary team effort."
It also helps that the hyperbaric oxygen unit at Nebraska Medicine is accredited by the Undersea and Hyperbaric Medical Society and one of 50 in the nation with the critical care capability and experience to participate in such a trial.
"We are one of the few units who can do critical care and are staffed 24 hours a day seven days a week, which was another reason we were asked to participate in the HOBIT trial," Dr. Cooper said.
So proud of your efforts, Dr. Cooper! Our entire community looks forward to the results of the study.