Clinical Studies

ProTECT (IRB# 32302)

Status: Active

 

Investigators:

  • Principal Investigator: James M. Leaming, MD, Department of Emergency Medicine
  • coPrincipal Investigator: Thomas Terndrup, MD, Department of Emergency Medicine
  • Investigator: Heidi Frankel, MD, Department of Surgery
  • Investigator: Philip Villanueva, MD, Department of Neurosurgery
  • Investigator: Claire Flaherty-Craig, PhD, Department of Neurology

 

Description:

ProTECT is a national research study evaluating the use of a hormone during a traumatic brain injury.  Penn State Hershey Medical Center is one of several academic medical centers nationwide participating in this study. This study uses 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.

 

Eligibility:

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

 

Additional Study Details:

Additional study details are available here.

 

Locations:

Other hospitals include Temple University, New York Presbyterian Hospital, Stanford University Medical Center and University of Texas Medical Center at Houston. 

 

Contacts:

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