Study To Research Impact of Progesterone on TBI Patients


Posted on 12th February 2010 by Gordon Johnson in Uncategorized

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Ironically, despite a strong recommendation from the authors of the Guidelines for the Management of Severe Traumatic Brain Injury that the use of steroids was NOT recommended for the treatment of severe traumatic brain injury, research in the area continues. The irony is that the Brain Trauma Foundation is supporting such research, despite the fact that they were the publishers of the Guidelines. The Guidelines were published in Journal of Neurotrauma, Volume 24, Supplement 1, 2007.

The latest guideline said this about steroids:

The majority of available evidence indicates that steroids do not improve outcome or lower ICP in severe TBI. There is strong evidence that steroids are deleterious; thus their use is not recommended for TBI.

Currently there is little enthusiasm for re-examing the use of existing formulations of steroids for treatment of patients with TBI. If new compounds with different mechanisms of action are discovered, further study may be justified.

I guess a lot has changed in less than three years. A nationwide study, named ProTECT, on the use of progesterone to treat moderate to severe brain injury will be conducted at 17 hospitals across the nation, it was announced Wednesday.;=detail&ref;=1057 Progesterone also known is a steroid hormone which is part of the female reproductive cycle.

The study, funded by the National Institute of Neurological Diseases and Stroke, will track 1,100 patients nationally for at least three years.

The goal of the research is to find out if the hormone progesterone can lessen the disability and death, that can stem from Traumatic Brain Injury, the leading cause of death and disability in those younger than 44 years old, according to the Brain Trauma Foundation.

Research with animals has found that progesterone may lessen brain damage resulting from TBI.

ProTECT is a double-bind study, and will evaluate patients with moderate to severe brain damage. The evaluation must take place within four hours of the injury, and enrolled patients will either be given a placebo or the progesterone intravenously.

The Food and Drug Administration is allowing hospitals to enroll patients without written consent because TBI patients may not be conscious or have the ability to make an informed decision right after their injury.

Four Detroit hospitals will take part in the study, namely Henry Ford Hospital, Detroit-Receiving Hospital, Sinai-Grace Hospital and Beaumont Hospital.

One of the last studies on the use of steroids for TBI was halted mid-trial because of hard evidence that it was doing more harm than good. We hope this one is monitored with extremely tight controls, with no vested stake in continuing the study if things start to go wrong.