Traumatic brain injury trial set to begin this summer

Over the past few years, medical researchers have begun focusing efforts on learning more about traumatic brain injuries. This recent focus is due not only to the large number of veterans who have returned from Afghanistan and Iraq with these injuries, but also the increasing frequency with which they occur among members of the general public. Indeed, statistics from the U.S. Centers for Disease Control and Prevention indicate that almost two million new cases of traumatic brain injury occur in this country each year. What is worse, doctors are only now beginning to understand the long term impact of even mild traumatic brain injuries.

Later this summer, doctors in a nationwide network spanning 40 hospitals will begin an important trial studying the effect of the hormone progesterone on patients who have suffered a traumatic brain injury. After the initial event that causes a traumatic brain injury, the brain experiences a "secondary cascade" of cell death, which in some cases may cause more damage than the initial injury itself. Research suggests that administering progesterone to traumatic brain injury patients in the first hours after injury could prevent this secondary wave of cell death. The hope is that the drug will help patients make a faster and fuller recovery.

Although many researchers are enthusiastic about proceeding with the current progesterone trial, some are critical of the trial's procedures. Specifically, those who arrive at a hospital emergency room with a traumatic brain injury may find themselves enrolled in the study without having provided their consent to doctors. The reason is practical: in many cases, people arriving at a hospital with a traumatic brain injury are unable to communicate with doctors. If doctors wait for family or loved ones to arrive before they begin treatment, they could lose valuable time to prevent further injury.

Generally, federal law prohibits drug trials from proceeding without patient consent. There is, however, an exemption for emergency treatments. The upcoming progesterone trial falls under this exception.

It is too soon to say whether this trial will lead to new ways of treating traumatic brain injuries, but previous research on progesterone has been promising. Unfortunately, those who suffer a traumatic brain injury carry a heavy burden, both emotional and financial, after they are hurt. Even if doctors are not able to repair the damage immediately, any treatment that shortens recovery time and improves a patient's long term prognosis is a step in the right direction.