Study tries common drug for use in traumatic head injury cases

UW physicians based at Harborview Medical Center are evaluating the use of magnesium sulfate in preventing the negative effects generally associated with severe head injuries. The study is being conducted under the leadership of Dr. H. Richard Winn, UW professor and chairman of neurological surgery.

A small Pennsylvania study has already demonstrated that, if administered soon after head injury, 47 percent of patients given magnesium sulfate had a good recovery as opposed to 23 percent in a group that received placebo (inactive medication), according to Dr. Nancy Temkin, UW associate professor of neurological surgery and biostatistics.

“There are indications that this very common, low-risk drug has the potential of improving functioning as well as for preventing epilepsy better than the anti-convulsants typically prescribed for individuals with severe head injuries,” says Temkin.

Magnesium sulfate is a common compound that has been prescribed since the 1930s to prevent seizures in pregnant women with high blood pressure. In head injuries, especially those occurring when the head is shaken violently in a whiplash-like motion, the cells pull apart and are damaged, resulting in cell death. The body’s reaction to this sort of injury includes swelling, increased pressure on the brain and decreased oxygen levels, which generally result in permanent disability, Temkin explains.

Magnesium sulfate appears to lessen this damage and prevent some seizures associated with brain injury.

Side effects with magnesium sulfate are minimal. Studies have shown that there may be a very small drop in blood pressure as well as a drop in calcium levels, but there are no other significant health effects.

“This drug is only effective if given as soon as possible after a head injury, probably no more than eight hours later,” says Temkin. “Since almost all our patients are unconscious when they arrive and family members are not always readily available, we want to be able to administer this drug without consent if the patient’s family can’t be reached quickly.”

Several individuals with severe head injuries have already received magnesium sulfate, and the results have been very encouraging. “We had a 19-year-old who was thrown from a truck who we all feared was going to be permanently disabled from his head injury,” says Pam Nelson, research nurse. “We have seen this type of injury hundreds of times and the victim usually winds up in a nursing home if he survives. The young man we treated with magnesium sulfate is now driving and working. His speech and some of his fine motor skills have been affected, but his recovery is unusually good.”

Investigators at Harborview have obtained funding from the National Institutes of Health to perform a 400-patient clinical trial to determine whether magnesium sulfate lives up to the promise suggested by individual cases and the small Pennsylvania study. Patients will be given either magnesium sulfate or a placebo in addition to standard treatment for head injury.

Researchers are now seeking permission from the federal government to enroll patients with serious injury without obtaining prior informed consent if family members cannot be located quickly. Researchers believe that the potential benefits of administering this drug outweigh the risk of the minimal side effects. Researchers invite public comment on enrolling patients without consent for this study. To comment, call (206) 521-1868, or write: Dr. Nancy Temkin, Harborview Medical Center, Box 359924, 325 Ninth Avenue, Seattle, WA 98104. ¶

Larry Zalin, Harborview