Brain Injury Patient Recovers with Radical New Drug

Story first appeared in The Detroit Free Press.

INDIANAPOLIS -- On the night of the Indiana State Fair stage rigging collapse, a mother had no idea whether her adult daughter would survive.

As Indiana University Health Methodist Hospital neurosurgeons operated on the injured young woman, hospital staff asked the family whether they wanted to enroll her in the experimental use of a drug to treat traumatic brain injury.  No proven medicine exists to treat traumatic brain injuries, but a sex hormone had produced promising results in earlier trials, the family learned.

At the time, the family did not know whether the patient, 30, would survive, much less say yes to anything ever again.  They chose to enroll her in the testing because it is what they felt she would want.

Eight months after the injury, the Pendleton, Ind., resident can walk and talk. She's in intensive rehabilitation in a Michigan facility, but she can already engage in those every-day activities that most people take for granted, like playing hide and seek and making cupcakes with her five year old daughter.

Neither the family nor her doctor knows whether she received the drug or the placebo, but they agree that her recovery has been remarkable.  The patient herself believes that she did receive the drug, because she has come so far with such a devastating injury.

In general young women recover from traumatic brain injuries better than young men, an insight that led scientists to study progesterone.  Studies with pregnant rats showed they recovered faster than nonpregnant rats, prompting the idea that progesterone, a hormone produced in high levels during pregnancy, played a role. Male rats who received progesterone also did better.  Now an international million study of 1,180 patients is exploring whether delivering progesterone to a victim soon after the injury makes a difference.  As of yet, there have been no drugs approved in the treatment of traumatic brain injury cases, this may be the first.

Doctors now provide supportive care to patients with traumatic brain injury, ensuring their blood pressure remains stable and their brains do not swell.  To be eligible to participate in the progesterone study, patients must have been injured within eight hours and be in a coma. Participants receive progesterone for the five days after the injury.  Doctors then follow the patients to see how they do on a variety of measures. An early preliminary trial of progesterone saw that the drug both lowered mortality and improved outcomes.

Neither patients nor health care providers will know for a few years whether they received progesterone or a placebo. So-called double-blinded trials -- such as the one the patient is in -- are standard in medicine to ensure that neither patient nor the doctor who is assessing them attributes faster, better recoveries to the drug being studied.

Finding patients within the window that treatment that would prove effective has posed a challenge.  Since some brain injury patients arrive at the hospital without identification, making it impossible for doctors to contact family members. In other cases, no one may know when the trauma occurred.

The patient was in the audience of the Sugarland concert on the evening of Aug. 13 when a gust of wind blew down the stage rigging at the State Fair's Hoosier Lottery Grandstand. Seven people died and dozens were injured.

She still doesn't know for sure what hit her that night, but she knows it was heavy. She has lost all memory of that night and the following three months.  At one point, doctors thought she might be paralyzed, but many of her abilities returned although she still can't use her left arm. This fall she will have another surgery on her skull.

BHR Pharma will do an interim analysis on results of the progesterone study at the end of this year and if the results are exceptionally good, they will make those results public.   If not, they likely will not have results until some time next year.

Still, patients like this one and another patient who is graduating from Purdue this spring have greatly impressed the medical community.  Most traumatic brain injury victims don't go on to graduate from college within a year of their brain injury.  That's a real spectacular outcome, and the medical officials don't even know if he got the drug or the placebo.

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