The fight against traumatic brain injuries (TBI) took a disappointing blow recently, when a highly anticipated treatment showed no benefit for treatment. According to a report in Medscape Medical News, researchers were hopeful that the administration of progesterone immediately following a TBI would improve brain function and diminish long term effects. The prevalence of TBIs continues to grow within the United States, leading to deaths and long term disabilities. Researchers are diligently working to identify a viable treatment and previous studies led them to believe that progesterone was a strong possibility.
More than 200 laboratory studies have researched the administration of progesterone to treat brain injuries. Animal testing showed a reduction in cerebral edema, which is the accumulation of fluid within the spaces of the brain. The fluid retention causes the brain to swell, increasing pressure against the skull. When this occurs, blood flow can become restricted, leading to significant decreased functioning and possible death. Cerebral edema is a common condition among brain injury patients and a procedure to prevent or treat it would provide a major accomplishment in the fight against TBI damage.
The Study Details
Early phased human trials reportedly resulted in less fatalities and better functioning over time. This is what led to widespread excitement over the latest round of trials. According to the Medscape article, the first of two Phase Three trials were conducted in the following manner:
***Researchers expected to test 1140 patients with severe, moderate-to severe, or moderate acute TBIs.
***The average patient age was 35 years old
***Patients were randomly administered an intravenous dose of progesterone or placebo within 4 hours of the initial industry
***Doses were administered regularly for 96 hours after injury
The study was halted short of the anticipated 1140 enrollment number due to what the article characterized as “futility in achieving the primary outcome”. The reported outcomes included:
***When compared to the placebo group, the progesterone groups showed minimal significance
***The progesterone group also exhibited a higher rate of phlebitis, which is vein inflammation
A second Phase Three trial was also undertaken, including 1195 patients between the ages of 16 and 70 years old. Doses of progesterone and placebo were administered within 8 hours of injury, continuing for 120 hours. No significant improvement was exemplified in the progesterone-treated patients, when compared to the placebo group. According to the report, there was also little difference in the rate mortality between the groups.
Dr. W. Wright, who authored the study, characterized the study results as “a stunning disappointment.” He further stated, “ Over 200 positive published studies in multiple laboratories, two pilot clinical trials, prompted immense enthusiasm for this study to finally [offer a] breakthrough and provide a positive treatment for traumatic brain injury.”
If you or a loved suffers with a severe brain injury at the hands of another, contact the experienced attorneys today.
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