Two Misses for Traumatic Brain Injury

Hans-Christoph Diener, MD, PhD


February 05, 2016

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Dear colleagues, I'm Christoph Diener, a neurologist from the Universitat of Duisburg-Essen in Germany. My topic today is traumatic brain injury, which is the most frequent cause of death in young people under age 45. There have been many attempts to reduce the long-term consequences of traumatic brain injury.

Today, unfortunately, I have to talk about two recent negative trials that were published in the New England Journal of Medicine. The first one[1] was a trial in Australia and New Zealand with erythropoietin, which has pleiotropic and neuroprotective properties. Research has shown that this drug is effective in animals with traumatic brain injury.

This study recruited 606 patients with severe traumatic brain injury within 24 hours. These patients received a placebo or three injections of 40,000 units of erythropoietin one week apart. The primary endpoint was the outcome on the Glasgow Outcome Scale (GOS) between 1 and 4, which represents a vegetative state and severe disability.

After 6 months, the percentage of patients with a poor outcome was 44% in the active treatment group and 45% in the placebo group. The mortality was 11% vs 16%. So this trial was clearly negative.

The second trial,[2] which was done in the United Kingdom, recruited patients who had increased intracranial pressure above 20 mm Hg. These patients were also treated with hypothermia with temperatures between 32º and 35ºC, depending on the increased intracranial pressure. The control group received standard care. The outcome was the value on the GOS, 1 to 8 in 6 months. This trial had to be terminated prematurely when it turned out that there was a 50% higher risk for a poor outcome in patients receiving hypothermia.

If, for example, we looked at one other endpoint, which is a reasonable outcome—GOS between 5 and 8—this was achieved in 26% only in the hypothermia group and 37% in the control group. So, hypothermia is not only not helpful but is obviously also causing damage.

Ladies and gentleman, unfortunately we have two negative trials, which complement the other trials that were reported earlier this year; those were two trials on progesterone[3,4] which were negative, and one trial on prednisone.[5]

So, at the moment, I think the only thing we can do is prevent traumatic brain injury as best as we can.


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