Health Check: Hormone therapy for traumatic brain injury
Every minute, four people in this country suffer a major traumatic brain injury. Every five minutes, someone is permanently disabled as a result.
That's why hospitals, including one in Rhode Island, are looking at a new treatment that could change all that.
In a room tucked away inside Rhode Island Hospital, researchers are hard at work on a study known as ProTECT.
"This really could change the game in terms of how we treat traumatic brain injury," said Dr. Lisa Merck.
Merck is an emergency room physician at Rhode Island Hospital and the lead researcher locally in the ProTECT study. "Pro" stands for progesterone.
"Progesterone is found naturally in both men and women, and the progesterone that's derived for this study is actually derived from a yam. It's not a human-derived product," Merck said.
In the lab, the use of progesterone in animals proved beneficial, decreasing the swelling in the brain on lab animals. Then, it was tried on people.
"There were two basic human trials that were completed, one in China and one in Atlanta that showed that infusion of progesterone was associated with a decreased mortality and morbidity after brain trauma," Merck said.
This study is being done nationally at 40 sites -- Rhode Island Hospital is one of them -- to see if progesterone along with the standard of care, which is mostly supportive, is better than the standard of care alone.
"All of the patients would receive the standard of care for moderate or severe traumatic brain injury," Merck said.
And some would receive infusions of progesterone as well.
"The potential side effects are things like phlebitis or inflammation at the infusion site, deep vein thrombosis or blood clots, pulmonary embolism. Those effects we know are associated with hormone therapy. That being said, this study has been running now and 800 patients have been enrolled nationally. The Data and Safety Monitoring Board from the (National Institutes of Health) has reviewed all of the adverse events throughout the trial and has deemed that it's safe to continue," Merck said.
This is not a trial where researchers need to get your permission first because if you've had a moderate to severe brain injury, you won't be able to give it. And since time is of the essence, there might not be enough time to talk to a legal guardian. But you can opt out in advance by registering for exception from informed consent.