Hennepin Healthcare Seeks Exception for Trauma Study on Blood Loss Treatment

Key Insights

• Hennepin Healthcare is seeking an exception to enroll unconscious trauma patients in a clinical trial without prior consent to study early interventions for blood loss.
• The study will investigate whether early administration of calcium and vasopressin, compared to a placebo, improves survival rates in trauma patients.
• The LITES Network-affiliated trial aims to enroll over 1,000 adult trauma victims nationally, with Hennepin Healthcare participating as one arm.

Hennepin Healthcare is seeking permission to enroll trauma patients, including car crash victims, who are unable to provide informed consent in a clinical trial investigating the early administration of drugs to reduce blood loss. The study aims to determine if earlier treatment with calcium and vasopressin during transport or hospital admission leads to improved survival rates.

Study Details and Rationale

Currently, doctors administer calcium and vasopressin to trauma patients experiencing blood loss, but typically after arrival at the hospital. Dr. Michael Puskarich, director of research in Hennepin Healthcare’s emergency medicine department, explained that bleeding can create a “vicious cycle,” making treatment less effective when initiated later. The goal is to intervene earlier and improve outcomes.

Hennepin Healthcare intends to join the Pittsburgh-based LITES Network, a national study planning to enroll over 1,000 adult trauma victims. Given that some patients will be unconscious or severely injured, researchers are requesting a federal exception to enroll them without prior informed consent. Once patients are stabilized or their family members are available, researchers will explain the study and seek their continued participation.

Treatment and Assessment

Participants will be randomly assigned to receive either intravenous calcium and vasopressin or a placebo. Researchers will then assess whether the treatment improves immediate survival odds and survival rates 30 days post-injury.

Ethical Considerations and Community Engagement

Due to the sensitive nature of enrolling patients without consent, Hennepin Healthcare issued a public notice about the study and is actively seeking community feedback before obtaining final approval from local and federal safety oversight boards. This approach follows criticism the hospital received in 2018 regarding a trial where paramedics administered ketamine to agitated patients without consent.

Puskarich emphasized the hospital's commitment to building public trust with this latest trial.