Community consultation was done via a randomized phone survey of over 500 Milwaukee County residents, 18 and over. When explained the design of the study, they overwhelmingly expressed support to proceed with the study. The Food and Drug Administration requires this community consultation because informed consent cannot be obtained from a patient suffering moderate to severe traumatic brain injury.
“This is very important research, which has the potential to save lives and improve outcome for this severely injured population,” said Dr. Aufderheide, who is an emergency medicine physician at Froedtert Hospital & the Medical College.
The goal of the study is to evaluate whether the naturally occurring hormone progesterone, when injected into patients within hours of a moderate to severe traumatic brain injury, can lower deaths and reduce paralysis and brain damage.
The medications will be administered by Froedtert Hospital staff. The standard of care will be equal to current standards.
For more information on exception from informed consent under emergency circumstances, risks and benefits, opt-out bracelets, or details of the study please call Dr. Tom Aufderheide, Professor of Emergency Medicine at the Medical College at (414) 805-6493 or email firstname.lastname@example.org, or visit the web site at www.mcw.edu/protect.