ProTECT Study

Penn State Milton S. Hershey Medical Center Department of Emergency Medicine is participating in a clinical research study called ProTECT -  a national research study evaluating the use of a hormone during a traumatic brain injuryAlthough currently on hold, Penn State Hershey Medical Center is one of several academic medical centers nationwide participating in this study. Other hospitals include Temple University, New York Presbyterian Hospital, Stanford University Medical Center and University of Texas Medical Center at Houston.

Learn more about ProTECT: 

This is an exception from informed consent study, meaning that patients who do not want to participate in this study must notify the Medical Center prior to needing EMS services. 

What is an exception from informed consent study?

Typically, a patient has the opportunity to discuss a research study before agreeing to participate. However, there are specific instances where a patient is not able to give his or her consent. In these instances, federal rules allow for an exception from informed consent study. This type of study can only be used when the person's life is at risk, the treatments we have don't work, and the study might help the person. The Medical Center follows strict federal guidelines to take part in this type of research study.

How will exception from informed consent work with ProTECT?

Since the patient will not be alert to give consent, study team members will try to locate a legally-authorized representative for one hour to get permission for the patient to enter the study. If a representative can't be located within one hour of the patient's arrival at the hospital, the patient will be started on the study medicine without consent. If the representative is located and does not give permission, the study medicine will be stopped.  Community members can also wear a bracelet informing medical personnel that they do not want to be part of the study. These bracelets must be worn at all times for the duration of the four year study and can be requested by visiting: >

 

What is ProTECT?

ProTECT, is research studying the use of progesterone, a steroidal hormone found naturally in the body, to limit the damage caused during brain injury. There is currently no drug treatment for traumatic brain injury; instead doctors attempt to control blood pressure and oxygen levels to minimize damage.

  • ProTECT trial video from our partners at the Neurological Emergencies Treatment Trials Network >> 

Why is this important?

Traumatic brain injury is sudden damage to the brain caused by an outside force, such as an automobile accident or a fall. Those who suffer a head injury are most likely to be treated at Penn State Hershey Medical Center, the region’s only Level I trauma center. 

What is traumatic brain injury?

Traumatic brain injury (or TBI) is a sudden damage to the brain caused by an outside force, such as a car crash, a fall, or something hitting the head. Penn State Hershey Medical Center is central Pennsylvania's Level I trauma center, treating patients who have this kind of injury. Traumatic brain injury can change the ability to think and remember things, cause problems with balance, coordination, fine motor skills like writing or tying a shoe, and strength. It can keep a person from being able to return to work or from functioning normally and independently. In addition, it can cause coma, permanent brain damage or death.

How is it treated?

There is no drug treatment for traumatic brain injury, with no new treatment being introduced in more than thirty years. The current treatment is to control blood pressure and oxygen levels to attempt to limit the amount of damage to the brain.

What is progesterone?

Progesterone is a steroidal hormone produced in the ovaries.

How is it used in this study?

Studies already conducted using animals show that giving progesterone shortly after a traumatic brain injury may reduce brain swelling and damage. A small study using humans has shown that use of progesterone does not cause harm and may decrease the amount of brain damage. This larger study is looking at if progesterone is helpful in treating in traumatic brain injury.

Who is eligible to participate in this study?

This is an exception from informed consent study (See below for more information).

  • People who are 18 years or older with a blunt closed head injury, with moderate to severe brain injury, and who can start the study medicine within four hours from the time of injury.
  • Who is not eligible to participate?
  • Those under age 18.
  • Those allergic to eggs.
  • Women who have breast cancer or other cancers of the female organs.
  • Pregnant women.
  • Prisoners or those in police custody.
  • Those wearing an opt out bracelet.

How does this study work?

People who are eligible for this study will be randomly entered into one of two study groups. One group will receive an intravenous (IV) mixture that includes progesterone. The other receives an IV without medication, called a placebo. Both groups receive standard medical care given for a brain injury. Both groups will receive the IV for four days and have blood drawn. They will then be called once per month for five months to see how they are doing; and will return for a clinic visit the sixth month to take a series of paper and pencil tests.

Are there risks?

As with any medical procedure, treatment, or medication, there are potential risks. These include:

  • a potential for the risk of blood clots to increase.
  • a potential for an increase in liver enzymes. 
  • a potential for an increased risk of infection.
  • a potential of pain, bruising, swelling, redness or infection at the IV or blood draw site. 

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Call: 717-531-1707 option 5

Who are the investigators participating in this study?

  • Principal investigator of this study is Michelle Fischer, MD, Department of Emergency Medicine
  • Co-principal Investigator, Thomas Terndrup, MD, Department of Emergency Medicine
  • Investigator, J. Christopher Zacko, MD, Department of Neurosurgery
  • Investigator, Claire Flaherty-Craig, PhD, Department of Neurology

The IRB and the Human Subjects Protection Office can be reached by calling 717-531-5687