Harborview drug study raises ethical dilemma.

SEATTLE -- Harborview Medical Center's trauma unit treats about 60,000 patients a year. Too often the victims of car accidents, falls and gunshot wounds arrive with traumatic brain injuries.

The doctor who leads the trauma unit believes she's got a drug that could help save lives and reduce the disabilities that often result from such injuries. She wants to battle-test it in the field.

There's just one problem: An unconscious victim cannot give consent for paramedics to administer the drug.

"We wouldn't do the study unless we thought it was safe," said Dr. Eileen Bulger, Chief of Trauma and a professor of surgery at the University of Washington. "Most people, once they understand the facts and safety of the drug, will say 'yes, sure, if I'm injured I want everything done for me as possible to improve my outcome.'"

The drug is Tranexamic Acid (TXA), a drug already approved by the FDA to stop internal bleeding. Bulger says it's been used with minimal side-effects in trauma centers for many years. She says the military also uses it in combat.

"We believe it could significantly reduce the internal bleeding in traumatic brain injury patients, as well," she said. "It's a drug that's been proven safe and effective."

Harborview received federal permission to proceed with a study, along with several other cities, that would entail having paramedics administer TXA to trauma victims in the field. Some victims would receive TXA while others would receive a saline solution.

The study could start in a couple months or so after the hospital performs a community outreach effort, a requirement to inform the public. If there is no significant opposition, the study will proceed.

A random sampling of comments from patients and visitors at Harborview showed there is some concern.

"I've got mixed emotions about it," said Lehua Peters. "It's the consent thing. I don't like that I can't say yes, this is what I want."

But a former trauma patient said it wouldn't bother him one bit, because paramedics treat unconscious people all the time.

"That's the whole point of being knocked out or passed out. When you come in they really have no choice but to do what they think they can to help you," said Harold McKenzie."

What would the doctor do if it was a member of her own family?

"If it were my family, my friends, my daughters who are driving, I would absolutely want them to receive this drug," Bulger said.

There is a way for any member of the public to opt out of the study.

You can email or call Harborview to request a bracelet to wear that would inform paramedics you do not want to receive the drug without consent in an emergency

A link to Harborview's study that includes more detailed info, a survey and a powerpoint presentation is available online