Risk/Benefit Public Announcement
Public Disclosure of an Exception to
the Requirements for Informed Consent under Emergency Circumstances for a Traumatic Brain Injury Study
in Milwaukee County
This announcement serves as public disclosure of a traumatic brain injury research study, called the ProTECT III Trial, that will begin March 2010 by The Medical College of Wisconsin and will be performed in Milwaukee County.
Every 15 seconds, a U.S. citizen sustains a significant traumatic brain injury (TBI). Every five minutes, someone is permanently disabled as a consequence of TBI. Between 1.5 to 2 million Americans sustain a TBI each year. In addition to the 50,000 deaths and 235,000 hospitalizations caused by TBI each year, there are over 80,000 Americans disabled. Another 37,000 patients experience moderate disabilities. The Center for Disease Control estimates that 5.3 million civilian Americans are living with some degree of disability from a traumatic brain injury.
The ProTECT III Trial will study the effectiveness of the hormone progesterone in reducing brain damage in patients with moderate to severe traumatic brain injury. To be included in this study, patients must be at least 18 years old, with a moderate to severe traumatic brain injury, and must be able to start the study medicine within four hours of their injury. Patients will be randomized (like flipping a coin) with a 50/50 chance that the study medicine given will contain progesterone. This means that half of the patients in this study will receive treatment with progesterone and half of the patients will receive placebo (a solution with no medical effect). All patients will receive either the current standard of care or the current standard of care plus treatment with progesterone. Patients included in this study will receive an intravenous (IV) infusion (given through a tube in the vein) of the study fluid (either progesterone or placebo) over 96 hours.
All medical treatments and all research contain risks. Like all medicines there is a risk of allergic reaction and discomfort at the site the IV (a tube in the vein). Other risks that have not been seen with this drug but could occur include blood clots, an increase in liver enzymes (a blood test that shows how well the liver is working) and infections.
The study fluid (progesterone or placebo [a solution with no medical effect]) is added to a mixture made of eggs, called Intralipid®. If allergic to eggs, this mixture could cause an allergic reaction.
There is a risk of bruising, swelling, and redness developing at the site of the IV infusion.
Risks will be closely monitored on an ongoing basis and the study stopped if it is determined that the study medication results in an increase in patient safety concerns. There may also be some unknown or unanticipated risks because the medication used in this study is an attempt to advance medical knowledge. Every precaution will be taken to assure personal safety.
The study medicine is a hormone that is naturally found in our bodies. There is information that suggests that this hormone, if given as soon as possible after injury, may help treat brain injuries by reducing brain swelling and damage.
The benefit that may reasonably be expected from participating in this study is reduced brain damage caused by traumatic brain injury and improved brain function six months after the injury, but these benefits may or may not occur. Further, this study may result in improved treatment for traumatic brain injury patients in the future.
There are no financial risks or benefits for study participation. All information obtained from this study that can be identified to an individual person will remain absolutely confidential. The scientific or medical information not identifiable with a patient resulting from the study will be presented at meetings and published so that the information can be useful to others.
Usually persons in a study must be given an explanation of it and agree beforehand to participate in it. This is called “informed consent”. It is not possible to obtain informed consent from patients with traumatic brain injuries. They are unconscious and will suffer further harm or die if not treated as quickly as possible. Their families may also not be available to speak for them. Under these emergency conditions, the United States Food and Drug Administration (FDA) allows studies like this to be done without first getting informed consent where there is reasonable scientific evidence to suggest a possible benefit from a new intervention. Therefore, this study will be performed under these federal regulations (21 CFR 50.24) where obtaining informed consent is not possible.
FDA regulations require public disclosure to inform the community that a research project will be done that may impact members of the local population. This disclosure must be made prior to the initiation of the study, which will begin March 2010, and continue for approximately 5 years. Public disclosure will also occur after the study is completed.
Interested parties with questions or concerns or requiring information on obtaining opt-out bracelets are encouraged to contact, Dr. Tom P. Aufderheide, either by phone (414-805-6493), mail (Department of Emergency Medicine, 9200 W. Wisconsin Ave.,, Pavilion 1P, Milwaukee, Wisconsin 53226 or email (firstname.lastname@example.org
), or visiting the WEB site at (www.mcw.edu/protect). Feedback from the community may be used to further modify the design of the study.