Drug trial to prevent blood loss could include Minnesota trauma patients without consent

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

The new federally funded study is called CAVALIER, an acronym for CAlcium and VAsopressin after Injury Early Resuscitation. The drugs studied in the research are effective but have established safety profiles, so earlier use is unlikely to cause complications or side effects, Puskarich said. But paramedics and emergency physicians are busy with trauma cases, he said, so the key question is whether prior drug use improves outcomes or just serves as a distraction that slows down treatment teams.

The Twin Cities regularly participate in trauma research through studies by Hennepin, as well as the University of Minnesota Medical Center and Regions Hospital in St. Paul.

Other emergency trials similarly waived the usual process of obtaining prior consent from patients. This includes the HOBIT trial, underway at Hennepin Healthcare and collaborating hospitals in Iowa and Nebraska, to determine whether hyperbaric oxygen therapy can reduce the damage of traumatic brain injuries. U Hospital, along with M Health Fairview’s Southdale Hospital in Edina, is participating in the national FASTEST trial to study whether medical treatment of brain bleeds can improve outcomes after a stroke.