$29 million grant funds research on fibrinogen in trauma care

The University of Colorado Anschutz Medical Campus will lead a groundbreaking national clinical trial-supported by a $29 million grant from Octapharma-to evaluate whether early replacement of fibrinogen, a critical blood clotting mechanism in the body, can improve outcomes for trauma patients experiencing life-threatening bleeding. This investigator-initiated study is one of the largest clinical trial grants in campus history.

The EFFECT Trial (Early Fibrinogen for Endotheliopathy and Coagulopathy in Severe Trauma) is a multicenter and randomized trial that will enroll 800 participants across 12 top-tier trauma centers across the country, including multiple UCHealth trauma centers. The study is a major collaboration between CU Anschutz and Octapharma, the global biopharmaceutical company that manufactures Fibryga, the fibrinogen concentrate involved in the trials.

This is the first U.S. clinical trial to rigorously evaluate early fibrinogen replacement with fibrinogen concentrate as a frontline intervention in trauma. It has the potential to redefine resuscitation practices and save lives by targeting one of the leading, and most preventable, causes of early trauma death: hemorrhage."

Adit Ginde, MD, principal investigator, professor of emergency medicine, and interim senior associate dean at the University of Colorado School of Medicine

Hemorrhage remains the primary cause of preventable death after traumatic injury, and fibrinogen is the first coagulation factor within the body to be critically depleted. While European trauma systems routinely use fibrinogen concentrate early in trauma care to slow patient bleeding, U.S. guidelines have lagged due to a lack of clinical trial data. The EFFECT Trial is designed to close that gap. Moreover, this research has the potential to transform how severely injured service members are cared for on the battlefield. By enabling rapid, portable fibrogen replacement in critical early moments of care, lifesaving treatment will be available closer to the time of injury.

The trial is notable not only for its clinical goals, but also for its innovative adaptive design. Investigators will use real-time testing to guide therapy and assess biological markers of coagulation, inflammation and hemmorage-inducing factors.

"This trial represents the future of trauma research: biomarker-driven, adaptive, and collaborative," said David Douin, MD, scientific lead for the trial and associate professor of anesthesiology at CU School of Medicine. "By integrating clinical outcomes with mechanistic data, we aim to deliver actionable science that improves both survival and long-term recovery."

Led by the University of Colorado Anschutz Medical Campus, the trial brings together a national network of elite trauma hospitals across the country, along with the Data Coordinating Center led by Tianjing Li, MD, PhD, professor of ophthalmology at CU School of Medicine and the Statistical Coordinating Center by Alex Kaizer, PhD, associate professor of biostatistics and informatics and Center for Innovative Design and Analysis at Colorado School of Public Health, and Vik Bebarta, MD (US Air Force Colonel Reserve), professor and interim chair of emergency medicine and director of the CU Center for COMBAT Research.

"We are honored to partner with the University of Colorado Anschutz Medical Campus on a trial of this scope and impact," said Flemming Nielsen, President, Octapharma USA, Inc. "The results of EFFECT will be foundational to advancing trauma care and strengthening clinical guidelines in the U.S. and globally."

With its rigorous design and national scale, the EFFECT Trial is expected to directly inform updates to civilian and military trauma resuscitation protocols. The data generated could support broader use of fibrinogen concentrate and influence trauma systems around the world.

"This project is a true collaboration-across academic and industry partners, across specialties, and across institutions. It's a remarkable opportunity to lead a potentially practice-changing trial at CU Anschutz that could save lives, and I'm deeply grateful for the strong relationships and shared commitment that make this work possible," said Ginde.