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Blood Loss Prevention Drug Study May Enroll Minnesota Trauma Patients Without Consent
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Blood Loss Prevention Drug Study May Enroll Minnesota Trauma Patients Without Consent

“One of the reasons there were problems with ketamine was because it didn’t fully go through the process” of getting a formal exemption from informed consent, he said. “That’s really what sets this apart.”

The new federally funded study is known as KNIGHTan acronym for CAcalcium and VAsopressin following Early Trauma Resuscitation. Research drugs are powerful but have established safety profiles, so earlier use is unlikely to have complications or side effects, Puskarich said. But paramedics and emergency room doctors are busy with trauma cases, he said, so the key question is whether using drugs earlier will improve outcomes or just serve as a distraction that slows down treatment teams.

The Twin Cities have been a regular participant in trauma research through Hennepin’s studies, but so have the University of Minnesota Medical Center and Regional Hospital in St. Paul.

Other emergency trials have similarly obtained waivers from the usual process of obtaining prior consent from patients. These include The HOBBIT Processongoing at Hennepin Healthcare and partner hospitals in Iowa and Nebraska to see if hyperbaric oxygen therapy can reduce damage from traumatic brain injury. The U Hospital, along with Southdale Hospital at M Health Fairview in Edina, is participating in the national competition Fastest process to study whether medical treatment of brain bleeding can improve outcomes after stroke.