Jan. 23 (Bloomberg) -- After retired race car star Michael Schumacher severely injured his head in a fall while skiing last month, doctors in France removed part of his skull to relieve dangerous swelling in his brain. How much their treatment will help in the long run is an open question.
Aggressive care for head injury can keep some patients alive and maximize the odds of recovery by preventing further damage. Even so, treatment often remains elusive -- an invasive, hit-or-miss process that requires months or years of rehabilitation with uncertain results.
Each year 50,000 Americans die from brain trauma and another 275,000 are hospitalized, according to the U.S. Centers for Disease Control and Prevention. Attempts to make drugs to protect injured brain cells have so far failed, so doctors’ main recourse to prevent the damage from spreading is relieving pressure inside the skull as well as removing blood clots.
“We desperately need a breakthrough,” said Peter Andrews, a critical care specialist at the University of Edinburgh.
Schumacher, 45, a seven-time Formula One champion, was placed in an induced coma by doctors after his accident. He has since undergone partial skull-removal as a way to relieve dangerous pressure, as well as surgery to remove blood clots in his head. Since Jan. 6, officials at Grenoble University Hospital Center in France, where he is being treated, have declined to update his condition. Schumacher’s condition was still stable on Jan. 17, according to an e-mail his manager, Sabine Kehm, sent to the Associated Press. Kehm declined to respond to questions from Bloomberg News.
Doctors rely on a variety of steps to manage brain swelling after a head injury. They monitor brain pressure closely and drain fluid from the brain or use saline solution or a diuretic to draw fluid out of brain tissue. If that doesn’t work, surgeons may remove a chunk of the skull to allow room for the brain to swell, as Schumacher’s doctors did. When possible, surgeons will also remove large clots that press dangerously on the brain.
The level of care “has dramatically improved over the past 10 or 15 years,” said Brian Walcott, a neurosurgeon at Massachusetts General Hospital in Boston.
A study announced last year found the severe head trauma death rate in New York hospitals dropped to 13 percent in 2009 from 22 percent in 2001 as hospitals became more consistent at following existing care guidelines. Still, doctors agree more needs to be done.
Partial skull removal, while it relieves pressure, is invasive and requires a second operation to replace the portion of removed skull. And a 155-person trial of patients with widespread damage found that removal worsened long-term outcomes compared with other treatment, according to results published in the New England Journal of Medicine in 2011.
Attempts to develop drugs that directly protect brain cells after traumatic head injury have failed so far. A 2012 review found 40 of 55 trials of drugs and other treatments for acute brain injury failed to help patients or made matters worse.
Relatively few pharmaceutical companies are testing new drugs to treat brain injuries. Instead, much of their effort is focused on testing new formulations of old drugs.
Remedy Pharmaceuticals Inc., a closely held New York-based drugmaker, is testing a new formulation of the generic diabetes medicine, glyburide, in patients with nervous system injuries. In low doses, the drug may act to stop fluid from accumulating inside injured brain cells, an action that leads to swelling, said Remedy Chief Executive Officer Sven Jacobson.
“If you can prevent the swelling, you are giving the patient who has no therapy at the moment a real chance of living,” Jacobson said.
Other trials are examining whether use of the hormone progesterone, which has various brain protecting effects, or tranexamic acid, an anti-bleeding agent, may help.
One extensive trial of progesterone sponsored by the U.S. government was halted this month after doctors concluded it was unlikely to help improve outcomes. Besins Healthcare, a closely held drugmaker based in Bangkok, expects results this spring from another 1,180-person trial testing infusions of the drug as a way to limit damage after head trauma, said Chris McNamara, a company spokesman.
The London School of Hygiene & Tropical Medicine is sponsoring a large trial on tranexamic acid that plans to include 10,000 patients in at least 10 countries with the goal of determining whether the drug can help reduce hospital deaths in head injury patients, said Haleema Shakur, co-director of the clinical trials unit, in an e-mail.
Trial results are expected by mid-2017, Shakur said.
Drugs may not be the only answer, according to Andrews, at the University of Edinburgh. He is leading the world’s largest trial of hypothermia, cooling the body down a few degrees, as a treatment for brain swelling in the days after an injury. While it is one of the treatments that Schumacher has received, according to reports, its benefit remains unproven.
The results of the trial being run by Andrews in 600 patients won’t be in for more than two years, he said.
Even a slight reduction in the death rate could save tens of thousands of lives each year around the world, given the large number of people who die of head injuries, often from car accidents, said Shakur from the London School of Hygiene.
“We are never going to have a magic bullet, but if we improve survival even by a small percentage it will be worthwhile,” she said.
--With assistance from Phil Serafino in Paris. Editors: Reg Gale, Rick Schine