- Drug is FDA approved for other uses
- Drug needs to be given immediately to be effective
- Brain-injury patients often unconscious, so drugs would be given without consent
- People are able to opt out
Harborview Medical Center wants to test a drug on unconscious patients without their consent, according to the Seattle times.
The experimental treatment would be used on about 100 victims who are taken to the hospital with traumatic brain injuries.
These kinds of human studies are allowed under federal law only if the community is well informed ahead of time.
The study could start this fall or winter but still needs final approval and that depends on how well community outreach on the topic goes.
The Seattle Times reports that Harborview is among 10 hospitals wanting to take part in the no-consent trial involving the Food and Drug Administration-approved drug, tranexamic acid.
It aims at preventing bleeding in the brain, specifically in people with traumatic brain injuries.
Doctors want to measure not only survival, but how the brain is affected after six months.
The Times explains because brain-injury patients are often unconscious and researchers believe the drug needs to be given immediately to be effective, brain trauma victims age 15 and older would automatically be enrolled in the program, unless a parent objects.
Emergency medical responders would inject them with the standard saline treatment or the experimental dose.
The hospital's outreach includes a local bicycle club, homeless shelters and non-English speaking communities.
People are able to opt out by calling 206-744-7724 to request a no study bracelet.
The study is funded by the U.S. Department of Defense and the National Institutes of Health.