ProTECT III Research Study

Traumatic Brain Injury (TBI) is sudden damage to the brain caused by an outside force to the head – such as a car crash, a fall, or something hitting the head.

• Every 15 seconds someone in the US suffers a major TBI.
• Every five minutes someone is forever disabled as a result of TBI.
• TBI is the leading cause of death and disability in children and adults 1-44 years of age.

TBI can affect a person’s ability to think and remember things, cause problems with balance and coordination, prevent a person from functioning independently, and cause permanent brain damage or even death.

ProTECT III is a research study designed to see if PROGESTERONE (a hormone normally found in our bodies) can reduce the amount of brain damage caused from a traumatic brain injury. Small studies in humans suggest that progesterone, given immediately after a TBI, may help treat brain injuries by reducing brain swelling and damage.

There is no specific drug treatment for traumatic brain injury. The reason for doing this study is to find out if progesterone is safe, and if it works better than standard medical care alone in reducing brain damage caused from a TBI. If progesterone helps brain injury patients get better, it will be a big improvement in TBI treatment.

• People who are 18 years or older with a
• Blunt closed head injury, with
• Moderate to severe brain injury, and
• Can start the study medication within four hours of the head injury.

People who meet the entry criteria will be randomly entered, like flipping a coin, into one of the two study groups:

• Those who get an IV mixture that has progesterone (the study medicine)
• Those who get an IV mixture that has no progesterone (also called placebo)

Everyone in the study will be given the standard medical care for brain injury.

Because we do not know which treatment is best for treating TBI, a person enrolled in the study may benefit from being placed in one study group over the other. Based on the information we get from this study, people who have a TBI in the future may benefit from what is learned from this study.

Possible risks of receiving the study drug progesterone include:

• Increased risk of blood clots in the body
• Increased risk of abnormal liver function
• Possible increased risk of infections
• Bruising, swelling or possible infection at the IV site

If you have egg allergies,a possible risk of receiving the IV mixture containing the study drug is an allergic reaction..
If you require care to treat conditions that are risks of participation, you or your insurer will be responsible for the costs of medical care.

Before the research study starts, meetings will be held in the community to provide information, answer questions, and get community members' thoughts and feelings about the study. There will also be information about the study in the media (for example, newspapers and TV)

If you would like to know about a community meeting near you or to get more information about the ProTECT III study, contact a local research study team member at the University of Maryland by calling 1-800-492-5538

If you decide you don’t want to be included, call us or send us an e-mail with your contact information. A bracelet with the words “ProTECT III declined” will be sent to you.  You would need to wear this bracelet at all times throughout the study period (approximately 4 years), or else you could potentially be enrolled in the ProTECT III study if you suffer a TBI in our community.

If you do not participate in the study, you will receive the standard medical treatment provided for traumatic brain injuries in your community.