What is Traumatic Brain Injury (TBI)?
TBI is sudden damage to the brain caused by an outside force (for example: car crash, fall, or something hitting the head).
TBI Background/Facts
Every 15 seconds someone in the US suffers a major traumatic brain injury (TBI), and 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 ages 1-44 years.
What are the long term effects of TBI?
TBI can:
- Affect one’s ability to think and remember things
- Cause problems with balance, coordination, fine motor skills (like writing or tying a shoe), and strength
- Prevent a person from being able to return to work, function normally or independently
- Limit awareness and cause coma
- Cause permanent brain damage
- Cause death
What is being done to treat TBI?
The current treatment for TBI is to stabilize the person by controlling their blood pressure and oxygen levels in order to try to prevent more harm to the brain.
What is ProTECT III?
ProTECT stands for “Progesterone for the treatment of traumatic brain injury” and is a research study to see if progesterone, a hormone normally found in our bodies, is useful in limiting the amount of brain damage from TBI. Many animal studies and two small studies in humans suggest that progesterone, given after TBI, may result in less brain damage. The ProTECT III study will test these findings and determine how helpful this treatment is in adults with moderate to severe TBI.
Why is ProTECT III important?
- No new treatment has been approved for severe TBI in over 30 years.
- Scientists have not found a useful drug treatment for TBI.
What is the purpose of this study?
The reason for this study is to find out if progesterone along with standard medical care works better than standard medical care alone to limit damage from TBI. If progesterone helps brain injury patients get better, it will be a big improvement in the treatment of TBI.
Who will be included in the study?
A person entered into ProTECT III must meet these four criteria:
- Be an adult (18 years or older) with
- A blunt closed head injury (nothing enters the brain), with
- Moderate to severe brain injury, and
- Be able to start study medication within four hours of the head injury.
Who will not be included in the study?
- Any person less than 18 years of age
- A person known to be allergic to eggs
- Women who have breast cancer or other cancers of the female organs
- Women who are pregnant
- Prisoners or anyone in police custody
How will someone be entered into the study?
People who meet the entry criteria for this study will be randomly entered, like flipping a coin, to one of two study groups. Everyone in the study gets the standard medical care for brain injury, but half of the patients will also randomly receive an IV fluid with progesterone. The other half will receive an IV fluid that does not contain progesterone, also called a placebo.
How is ProTECT III different from other studies?
Normally, members of the research team ask for permission before a person can enter a study. If a person is not awake due to a TBI or another medical problem, the research team might ask for permission from the patient’s legally authorized representative (LAR) or the person legally responsible for the patient, when one is present. However,traumatic brain injury must be treated quickly and there might not be enough time to find and talk to the LAR about the study. For this reason, a person with TBI might be enrolled into ProTECT III without getting permission. This is called “Exception from Informed Consent” (EFIC).
What is Exception from Informed Consent (EFIC)?
The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.
EFIC applies only when:
- The person’s life is at risk, and
- The treatments we have don’t work, and
- The study might help the person, and
- It is not possible to get permission:
- from the person because of his or her medical problem nor
- from the person’s legally authorized representative because there is a very short amount of time allowed to treat the medical problem.
Before researchers may do a study using EFIC, they must give information about the study to the community and get their feedback. This is known as public disclosure and community consultation.
What are the benefits of this study?
Because we do not have a treatment that is best for treating TBI, a person enrolled into this study has a chance to directly benefit from receiving the progesterone treatment.
Based on the information we get from this study, people who have TBI in the future may benefit from this study.
What are the risks of the study?
It is possible that one of the two study treatment groups may have a better outcome. If this is the case, people in one treatment group may not have as good an outcome as those in the other group.
The possible risks of Progesterone include:
- Blood clots in the legs or lungs that could lead to a heart attack or stroke
- Raised liver enzymes (a blood test that shows how well the liver is functioning)
- Possible infection including: infection in the lung, blood or tissue around the brain
- Other risks not yet known
Are tiny amounts of ethanol (alcohol) in the ProTECT study drug haram?
Please click here for the answer.