Houston hospitals set to take part in trial for those with brain trauma
Patients taken to Houston’s two renowned ERs with severe brain trauma will have an additional hole drilled in their skulls as part of a national trial to evaluate the potential benefit of treatment based on oxygen levels.
Doctors will insert a monitor into the new hole to measure the amount of oxygen in brain tissue, a practice already used by some doctors but not considered the standard of care. Such monitoring allows doctors to increase oxygen intake when monitor
ing shows brain tissue is getting less than normal levels.
“It’s used by some doctors and not others,” said Dr. Elizabeth Jones, an emergency medicine doctor at McGovern Medical School at UTHealth and leader of the trial’s South Texas sites. “But because a trial hasn’t been done, there’s no strong evidence that it benefits patients, that it translates into better outcomes.”
The Texas sites are the trauma centers at Memorial Hermann Hospital, Ben Taub Hospital in the Texas Medical Center and at the UT Health Science Center at San Antonio.
The trial, likely to begin next month, is another example of a once-controversial, now commonly accepted practice allowing research without patient consent if the patient is incapacitated. Now researchers are only required to inform the community ahead of such studies. Those who do not want to participate must opt out before they become a patient.
An estimated 120,000 Americans are hospitalized annually for severe traumatic brain injuries. Less than 25 percent make a good recovery and many are left with lifelong disabilities and medical needs.
Under the current standard of care, a monitor is inserted into the brain to measure the swelling, or pressure, that occurs within the skull following head trauma. Complications from such pressure, such as bleeding and herniation, can be deadly.
But Jones notes a lack of sufficient oxygen can also be fatal or cause complications due to a loss of brain cells. She said 70 percent to 86 percent of severe brain trauma patients suffer episodes of low oxygen, lasting on average 16 hours.
Doctors who already monitor oxygen intake believe it allows for more timely interventions to increase levels, a hypothesis bolstered by a preliminary study to the new one that hinted at more favorable outcomes in patients monitored for both pressure and oxygen intake.
Jones said previous studies showed no significant risks from drilling the additional hole and the Food and Drug Administration approved the oxygen monitors following studies that demonstrated their safety. She noted the monitors are expensive, so researchers want to make sure they produce better outcomes before recommending routine use.
The trial, which will be conducted over the next five years at 45 sites across the country, is expected next month to begin enrolling patients in Houston. All of the patients will have pressure and oxygen monitors placed within six hours of arrival at the hospital and then be randomized to monitoring for oxygen and pressure or just pressure.
People who do not wish to participate in the study should email clinicaltrials@uth.tmc.edu to obtain an opt-out bracelet that must be worn for the next five years.