Drug study on blood loss prevention may enroll Minnesota trauma patients without consent

Hennepin Healthcare is seeking permission to enroll car-crash victims and other traumatic-injury patients who are too injured to provide informed consent in a clinical trial of two drugs that reduce blood loss.

Doctors already administer calcium and vasopressin to patients who have lost blood because of traumatic injuries, but typically not until after they have been transported by ambulance from accident scenes and wheeled into surgery. The goal of the study is to determine if earlier treatment during transport or hospital admission can lead to less blood loss and better survival rates.

Bleeding can start a “vicious cycle” by the time patients reach intensive care units or operating rooms, said Dr. Michael Puskarich, director of research in Hennepin Healthcare’s emergency medicine department. “We get behind the eight ball and sometimes, when we start giving these treatments, it might be too late.”

Hennepin is aiming to become one arm of a national study in the Pittsburgh-based LITES Network, which will be enrolling more than 1,000 adult victims of traumatic injuries. Because some patients will be unconscious or too injured to give permission, researchers are seeking a federal exception to enroll them without prior informed consent. Researchers will then explain the study and its goals to patients once they are stabilized, or to their family members, to gain their continued participation.

Patients will either receive actual medications intravenously, or a nonmedicating placebo for comparison. The researchers will study whether their survival odds improve right away, and 30 days after their injuries.

The hospital issued a public notice about the study last week because of the unique situation regarding patient consent, and will be seeking feedback from the community before gaining final approval from at least three local and federal safety oversight boards.

Hennepin Healthcare was criticized in 2018 over a trial in which paramedics were reportedly administering ketamine to subdue agitated patients without their consent — sometimes with the urging of law enforcement officers on emergency scenes.

Puskarich said the hospital is taking steps to build public trust with the latest trial.

“One of the reasons the ketamine issues were there was because it did not go through this process fully” of gaining a formal exception from informed consent, he said. “That’s really what differentiates this.”

The new federally funded study is known as CAVALIER, an acronym for CAlcium and VAsopressin following Injury Early Resuscitation. The drugs in the research are potent but have established safety profiles, so earlier use is unlikely to present complications or side effects, Puskarich said. But paramedics and emergency room doctors are busy in trauma cases, he said, so the key question is whether earlier drug usage will improve outcomes or just serve as a distraction that slows treatment teams down.

The Twin Cities have been a regular participant in trauma research through studies by Hennepin, but also the University of Minnesota Medical Center and Regions Hospital in St. Paul.

Other emergency studies have similarly gained waivers from the usual process of gaining prior consent from patients. They include the HOBIT trial, underway at Hennepin Healthcare and collaborating hospitals in Iowa and Nebraska, to see if hyperbaric oxygen therapy can reduce the damage of traumatic brain injuries. The U hospital, along with M Health Fairview’s Southdale Hospital in Edina, are participating in the national FASTEST trial to study whether a medical treatment of brain bleeding can improve outcomes after a stroke.