Sanford Health hospitals in Fargo seeking public input on blood loss clinical trial

Courtesy: Sanford Health
Courtesy: Sanford Health

(Fargo, ND) -- Sanford officials are asking for feedback from the public regarding a nationwide clinical trial surrounding a blood coagulating drug.

Sanford Fargo is looking to participate in a national clinical trial and they are looking for feedback from F-M area residents. The trial looks to study a blood clotting drug named Kcentra®, otherwise known as 4-factor Prothrombin Complex Concentrate. The FDA approved drug is currently use to reverse the effects of blood thinning medications for patients that require surgery.

The study will look to see if it has applications in an emergency room or trauma setting; for events like car accidents and other severe incidents. Patients who participate will receive one of two options, Kcentra® or a placebo. The patients will then be monitored for multiple days to ensure good outcomes. The study will look at seriously injured patients who's lives are potentially in danger.

Sanford officials say these significant blood loss events that require immediate interventions will oftentimes be done under high stress and difficult circumstances. Community members can opt out of the clinical trial by completing the survey and sharing this with Sanford, who will automatically be opted out if they were involved in a high-blood loss event. 

"These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time. Most patients will be unconscious, unable to speak or hear, and too sick to consent to immediate treatment, or participation in the study, "said Sanford in a press release sent to WDAY Radio, "If the community feedback is positive and an independent review board (IRB) approves the study at Sanford Health, then Sanford Health will participate in this trial."

“The results of this study have the potential to change the way trauma patients are treated,” said Dr. Zreik. “If we can determine that Kcentra® is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”

The trial would begin in the spring of 2023 and continue until 2026. You can leave comments for Sanford Health about the clinical trial by clicking here

Original Air Date: 
Thursday, February 2, 2023