Atlanta Drug Treatment Help: New Emergency Treatment for TBI
A promising new treatment for traumatic brain injury, the first significant advance in 30 years, is now being tested in a large scale, multi-center clinical trial. Over the next three to four years, 17 participating trauma centers in 15 states will enroll more than 1100 patients with severe TBI. Half of the patients with severe head injuries will be given an infusion of the hormone progesterone as well as all standard treatment for TBI; the other patients will be given a placebo infusion, which contains no active agents, and as well as all standard treatment. The study will evaluate the protective effect of the hormone progesterone when it is administered within four hours of the injury. The study is double-blinded, meaning neither patients nor treatment staff will know which infusion the patient receives.
Progesterone is familiar to most people as an ingredient in birth control pills, and a hormone involved in pregnancy. It is present in small amounts in the brains of both men and women, and all human brains have abundant receptor sites for it. Progesterone’s beneficial effects on laboratory rats have been well documented: it was known to reduce swelling, and has a protective effect on damaged brain tissue. It is relatively inexpensive, easy to administer, and can cross the blood-brain barrier.
Currently there are no drugs with which to treat brain injury. Standard treatment is supportive: stabilizing the patient, maintaining other vital functions such as blood pressure and breathing, treating other injuries, minimizing infections, and monitoring swelling.
The ProTECT III (Progesterone for Traumatic brain injury – Experimental Clinical Treatment) study follows a smaller trial of progesterone treatment at Grady Memorial Hospital in Atlanta, GA. The goal of the first study was simply to determine whether progesterone was safe to administer. Researchers not only confirmed that the hormone was safe, they also saw dramatically better responses from patients with severe head trauma who received an infusion of progesterone started within the first four hours after their injury. Survival rates for people with severe injury increased 50%, and among survivors, brain swelling was significantly reduced. Swelling after injury is one of the chief causes of damage to the brain, and reduced swelling allows brain tissues to respond to the trauma with less permanent damage. Healing was faster and degree of disability was reduced.
Another major progesterone study, examining its usefulness for child and adolescent patients with TBI, is now in the planning states at the University of Michigan. Children and adolescents’ brains are still developing, and the effect of progesterone on the developing brain needs to be better understood.
The Phase III study now underway will require about four years to treat and evaluate its quota of 1100 patients. Until all the outcome data is analyzed, the treatment remains experimental and not available outside the study. Researchers and physicians involved remain very hopeful. If progesterone performs as expected, it will be a major advance in the treatment of TBI, another tool to help injured patients regain as much function as possible.
San Diego personal injury lawyer David S. Casey has dedicated his practice to providing legal representation for victims and their families who have suffered serious injuries or death due to traumatic brain injury. Throughout his 30 year career as a San Diego traumatic brain injury attorney, Mr. Casey has been recognized by his peers; he was named Lawyer of the Year in 2002 by the San Diego County Bar Association, and was the recipient of the Broderick Award for Civility, Integrity and Professionalism in 2004.
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