Reporting Dr. Maria Simbra
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PITTSBURGH (KDKA) — Kevin Conwell, 21, injured his head in June 2011.
He was on his way to work as a summer camp counselor when his car flipped. Since he was alone, no one knows for sure what happened – even Kevin.
“I just remember, like, waking up in a car with like ambulances,” he says.
He was rushed to Allegheny General Hospital, getting all the customary care for trauma. But he was also offered a chance to be in a research trial looking at whether hormones — specifically five injections of progesterone — will help. The decision had to be made quickly — within eight hours of the injury.
Kevin’s brain was bleeding deep inside and it was badly swollen. Even part of his skull had to be removed. His mother said yes to the study.
“It’s something that occurs in nature, naturally,” says Pauline Conwell, “and when your child’s in that bad of shape, if there’s no down side, then it was no brainer.”
Progesterone plays a role in the menstrual cycle and pregnancy, and it’s made in the ovaries in women, and in the adrenal glands in women and men, and in certain nerve cells. Steroids have a protective effect on the swollen brain, and progesterone has a similar chemical structure to steroids.
It’s a possible reason why females do better than males with traumatic brain injury.
“The effect of the drug is to decrease the inflammation and brain swelling,” explains Dr. Khaled Abdel Aziz, a neurosurgeon at Allegheny General Hospital.
The study is a phase III, randomized, double blind, placebo-controlled trial. This means previous trials have shown progesterone to be safe and effective and neither the doctors nor the patients know whether they’re getting progesterone or placebo.
With this study design, the goal is to show it is actually the progesterone that makes the difference.
“We say it clear to the family that this is an experimental medication,” says Dr. Aziz.
To qualify, you have to be between 18 and 70 and be moderately to severely impaired by the brain injury, based on eye opening, movement and verbal response. Gender does not matter.
Kevin had last rites given that day of the terrible accident. Today, he is doing things that surprise everyone.
“We never thought he would be up walking around, talking. He’s actually auditing a class at this point,” Pauline says. “All of us are very anxious to see whether he got the placebo or whether he got the drug.”
“When you’re severely injured or traumatized, you’d do anything to get your loved one back,” says Dr. Aziz. “I think there’s nothing better than seeing a sick patient gets, recover. And it brings happiness to everyone.”
Whether Kevin’s success is due to progesterone is not yet clear. At the moment, there are no FDA approved medicines to treat traumatic brain injury specifically.
Officials say 115 medical centers across the country are participating in the trial, with the goal of enrolling 1,200 patients. Right now they have nearly half that. Results are expected in late 2013.
In order for progesterone to be FDA approved for use as a medication for traumatic brain injury, this study will have to show it works better than placebo.