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Experimental Treatment After Traumatic Brain Injury Raises Questions Of Consent For Emergencies

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"We begin this week with a case study at how to test a new treatment while bypassing one of the basic rules of bioethics: informed consent... Starting this fall, ten hospitals around North America are testing a drug called tranexamic acid to see if it reduces bleeding in the brain following a traumatic head injury, but here's the ethical snag: a person who's just had a brain injury is in no condition to give consent to an experimental treatment so the drug will be administered without conventional informed consent. In a few moments, we're going to speak with Dr. Eric Meslin about the ethical questions this poses and how they are being addressed. But, first, Sound Medicine contributor Eilís O’Neill reports on the medical aspects of the treatment, from one of the test sites, Harborview Medical Center in Seattle."

Eileen Bulger: Traumatic brain injury is a tremendous public health problem. It’s devastating injury. It’s life-threatening. And for those who survive it, they often have long-term disability.

Eilís O’Neill: Dr. Eileen Bulger is Chief of Trauma at Seattle’s Harborview Medical Center and will be running the study about whether or not tranexamic acid can reduce mortality and disability in patients with traumatic brain injuries if it’s administered at the scene of the injury by emergency medical providers. Currently, traumatic brain injury is the leading cause of death for people under 40 years old. Thirty nine percent of those who get a traumatic brain injury die from it, and an additional 21 percent live, but with a severe disability. Most patients don’t die from the initial impact but rather from the damage caused by bleeding inside the skull, Dr. Bulger explains.

Eileen Bulger: You can imagine that if you’re bleeding in a tight space inside the skull that you don’t have a lot of room. And blood puts pressure on the brain and causes further damage. So, if we can reduce that pressure and reduce that bleeding, we think patients will benefit from that.

Eilís O’Neill: In recent decades, medical researchers have learned more and more about how traumatic brain injuries, or TBIs, work. But they’ve developed very few new treatments. Sometimes, doctors remove portions of the skull to try to reduce the pressure of bleeding on the brain. Or they give patients a standard saline treatment to try to slow the bleeding. Despite these attempts, outcomes for TBI patients have improved very little since 1990. Dr. Bulger hopes her study on tranexamic acid will change that.

Tranexamic acid is used to reduce bleeding in surgery patients or in women who have uncontrollable bleeding after childbirth. In 2010, a study of 20,000 adult trauma patients showed that tranexamic acid reduced mortality. But, until now, the drug has not been tested on TBI patients in a large-scale study.

Eileen Bulger: It’s been tested in brain-injury patients in a couple of smaller studies which have shown safety and have also suggested that there was a reduction in the progression of bleeding inside the brain. When the study starts, paramedics will use information like the patient’s blood pressure, pulse, type of injury, and level of consciousness to determine whether or not to administer tranexamic acid. They won’t be able to get the patient’s informed consent to participate in the study.

Eilís O’Neill: That has generated some controversy in Seattle. Outside the Wallingford Center in North Seattle, one 34-year-old who says he’s a regular cyclist says, if he got hit on the head while riding, he wouldn’t mind being treated with tranexamic acid.

Brent Sowers: If it could potentially help save a life, I think that’d be a great thing. Dire circumstances warrant dire methods, you know. Clearly, it’s been approved for other uses, so, I mean, there’s no reason it shouldn’t be tested for that particular use.

Eilís O’Neill: Another cyclist, who says he rides his bike to work every day, is still on the fence.

Matt: Trauma is tricky, right? You may have only seconds to make a decision that could save someone’s life. So, in that way, it’s different than going to your primary care doctor and he or she asks you for consent. So, in the case of trauma, I don’t know. You sort of have to trust your doctor, even if you may have no idea who that person is; you’ve never met them before.

Eilís O’Neill: Waiting by the bus stop, a 54-year-old woman says she’s completely against the study.

Carrie Philips: I’m not in favor of any sort of non-consent for a clinical trial. I work at a hospital here. I work at Swedish, and that’s not okay. There’s just too much that we don’t know about a drug, be it clinical one, trial, or through clinical form. No. You have a right to have a say what happens to your body. That’s a basic right, I believe.

Eilís O’Neill: Back at Harborview, Dr. Bulger says there are federal guidelines that govern studies in which health care providers go ahead with experimental treatments without their patients’ prior knowledge.

Eileen Bulger: You have to have an intervention that has a good safety profile, that has the potential to directly benefit people that are enrolled in the study, and is used in a life-threatening circumstance where there isn’t the opportunity to take the time to obtain consent—formal consent. That doesn’t mean we never get consent, because we do very soon after the patients arrive at the patient—but, most of the time, they’re still unconscious, because they were unconscious in the field to get into the study—or their family members. And we tell them about the study, and we get their permission to remain in the study.

Eilís O’Neill: Currently, Harborview researchers are trying to let Seattleites know about the study by talking to the media and reaching out to specific, at-risk groups, like the Cascade Bicycle Club. They’re also conducting a random-digit dialing phone survey—and, if a majority of Seattleites object to the study, they won’t go forward with it. And they’re providing an opt-out option: If you don’t want to be part of the study, you have to call Harborview, ask for a “no-study” bracelet, and then—here’s the catch—wear that bracelet for a year, till the study ends. So far, Harborview has sent out about sixty bracelets. The 26-year-old who cycles to work every day says he’d prefer an opt-in study model.

Matt: It seems unlikely that they would be able to reach enough people in the community that that would really be an effective way to get consent, right?

...

Barbara Lewis: Let's talk about this exception from informed consent in emergency circumstances. Is that exception one that is used a lot?

Dr. Eric Meslin: Not a lot. It's one of those small, but important parts of medical research studies that took some time to get federal approval, because as you can imagine, carrying out medical research always requires informed consent but here's a case where informed consent can't be obtained, but it might never be obtained from the person who want to do the study on. 

Lewis: What do you think of this trial that's being conducted?

Meslin: This is a study that's important in a lot of different ways. Principally, because people with traumatic brain injury are almost the most vulnerable people you can imagine in society, a terrible illness that not only prevents them from participating in decisions but could severely affect their life and their lifespan. So, studies that could be carefully designed that might hold out as the guidelines are pretty important but they just have to be done in an ethical way. 

Lewis: How do you think the people running the study should publicize what they are doing, to at least give people a chance of understanding of what's going on? 

Meslin: This is an issue of how do you not only inform people of the possibility of a study so that they are aware of it, but the federal rules say that you have got to publicize these kinds of things, a kind of community consultation approach. But they also have the ability to let people opt out or say they don't want to participate. When these regulations were first designed we didn't have Facebook and social media platforms and ways of getting the word out. So, I think the idea of being able to inform the public that there's an important study going on is much easier now than it was before. 

Lewis: The opt out bracelet. Is that enough? What else might be done? 

Meslin: There's no end to what could be done. It's how much is feasible, how much is possible. You could go from television to radio to the internet... As much information as you can get out the better. Unfortunately, you might not get all that information out. And having someone find one of those wristbands that tell people what your medical condition is is probably still the best way of indicating you don't want something done. However, people still have to get them, they have to wear them and know about the study.