The University of Colorado Anschutz Medical Campus has secured one of the largest clinical trial grants in its history—a $29 million award from Octapharma—to lead a groundbreaking national study evaluating early fibrinogen replacement in trauma patients experiencing life-threatening bleeding.
The EFFECT Trial (Early Fibrinogen for Endotheliopathy and Coagulopathy in Severe Trauma) represents a multicenter, randomized clinical trial that will enroll 800 participants across 12 top-tier trauma centers nationwide, including multiple UCHealth trauma centers. This investigator-initiated study marks a major collaboration between CU Anschutz and Octapharma, the global biopharmaceutical company that manufactures Fibryga, the fibrinogen concentrate being evaluated in the trial.
First U.S. Trial to Evaluate Early Fibrinogen Intervention
"This is the first U.S. clinical trial to rigorously evaluate early fibrinogen replacement with fibrinogen concentrate as a frontline intervention in trauma," said Adit Ginde, MD, principal investigator, professor of emergency medicine, and interim senior associate dean at the University of Colorado School of Medicine. "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."
The trial addresses a critical gap in trauma care protocols. 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. 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.
Innovative Adaptive Trial Design
The EFFECT Trial is notable for its innovative adaptive design, incorporating real-time testing to guide therapy and assess biological markers of coagulation, inflammation, and hemorrhage-inducing factors. This approach represents a significant advancement in trauma research methodology.
"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."
National Collaboration and Military Applications
The trial brings together a national network of elite trauma hospitals, supported by specialized coordinating centers. The Data Coordinating Center is led by Tianjing Li, MD, PhD, professor of ophthalmology at CU School of Medicine, while the Statistical Coordinating Center is directed by Alex Kaizer, PhD, associate professor of biostatistics and informatics at Colorado School of Public Health. Vik Bebarta, MD (US Air Force Colonel Reserve), professor and interim chair of emergency medicine and director of the CU Center for COMBAT Research, also plays a key role in the collaboration.
The research has significant implications for military medicine, potentially transforming care for severely injured service members on the battlefield. By enabling rapid, portable fibrinogen replacement in critical early moments of care, lifesaving treatment could be available closer to the time of injury.
Industry Partnership and Global Impact
"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 worldwide.
"This project is a true collaboration—across academic and industry partners, across specialties, and across institutions," said Ginde. "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."
