Injuries claim the lives of more than 4 million people worldwide each year, with uncontrolled bleeding being the leading cause of early death following severe traumatic injury. Most trauma deaths occur before an injured patient can get to a hospital, but trauma-related hemorrhage remains a life-threatening challenge in the emergency department.
These patients often need blood transfusions, but logistical challenges can make delivery of blood products slow, complicated, or even risky in a trauma-care setting, especially in remote areas or on a battlefield.
Now, Adit Ginde, MD, MPH, professor and vice chair for research at the University of Colorado Department of Emergency Medicine (DEM), will lead a nationwide, five-year clinical trial investigating a way to potentially reduce deaths from trauma-related hemorrhage by stopping bleeding faster, and also lessen the need for transfusions.
“We have the opportunity to lead the definitive clinical trial work in early fibrinogen replacement that could save lives for trauma patients around the country and around the world,” Ginde says. “This is a critically important question. Emergency physicians, trauma surgeons, and intensivists need the answer to this issue, so this trial will be followed with interest.”
CU School of Medicine Dean John Sampson, MD, PhD, MBA, recently appointed Ginde interim senior associate dean of medicine for clinical research. Ginde also is interim assistant vice chancellor for clinical trials in the CU Anschutz Office of Vice Chancellor for Research.
The investigator-initiated study is receiving $28.9 million in funding from global pharmaceutical company Octapharma. It’s one of the largest grants for a single clinical trial in the history of the CU Anschutz Medical Campus.
“At Octapharma, we believe the most meaningful advances come from true collaboration. CU Anschutz’s leadership in emergency and trauma research makes them an ideal partner, and together we hope to deliver evidence that transforms how patients with life-threatening bleeding are treated,” said Flemming Nielsen, president of Octapharma USA, Inc.
Ginde says Octapharma’s support is an example of the value of “embracing academic-industry partnerships” at a time when investigators face new challenges in securing research funding.
“Our federal grants remain a critically important part of our research portfolio,” he says. “But when our interests and expertise align with industry partners, including drug and device companies, then important, practice-changing work can happen. And that’s what we’re hoping can happen here.”
David Douin, MD, associate professor of anesthesiology, is the trial’s scientific lead. He says the project “could represent a big step forward in caring for trauma patients who are bleeding. Currently, bleeding patients receive blood transfusions to save their lives, but every blood transfusion carries some risk. Our trial will test an FDA-approved medication that could reduce the amount of blood transfusions we need to give to bleeding trauma patients.”
Blood clotting relies on fibrinogen to stop bleeding, but trauma patients lose it quickly, which can lead to uncontrolled hemorrhaging. The EFFECT trial will test whether Fibryga, which replaces fibrinogen, can potentially reduce deaths from trauma-related hemorrhage by stopping bleeding faster, and also lessen the need for transfusions.
A protein called fibrinogen plays a role in blood clotting, helping to stop bleeding and health wounds, but hemorrhaging trauma patients lose this protein quickly, reducing the blood’s ability to clot. A shortage of fibrinogen can also lead to a breakdown in the endothelial lining of blood vessels, potentially causing leaks.
“When you have major injuries, your body’s ability to form blood clots is often impaired, and the loss of fibrinogen is a key component to that,” Douin says. “So the goal is to have a way to replace it quickly, effectively, and safely.”
The new trial is called EFFECT, for Early Fibrinogen for Endotheliopathy and Coagulopathy in Severe Trauma. The trial will seek to answer whether use of Fibryga, a treatment produced by Octapharma that replaces fibrinogen, can help patients with severe bleeding when given early in the emergency department (ED). Researchers will also look at whether use of Fibryga affects the need for blood transfusions.
Fibryga is a fibrinogen concentrate made from purified human plasma. It was approved by the U.S. Food and Drug Administration in 2017 for treating people with certain inherited fibrinogen problems and in 2024 for those with low fibrinogen levels during major bleeding.
Ginde says the new trial is needed to evaluate effectiveness when used rapidly to treat major hemorrhage in severely injured patients.
“We already use it in the operating room for non-trauma patients, but there’s not enough data on using it in the context of major trauma and major bleeding,” Ginde says.
The EFFECT trial, which is slated to begin enrollment in 2026, will be conducted at 12 top trauma centers nationwide, including multiple UCHealth hospitals in Colorado. About 800 patients will be enrolled in the study.
The trial will include patients age 16 or older brought to the ED within four hours of their injury and who are expected to be admitted to emergency surgery or intensive care and receiving rapid blood transfusion.
One group of patients will receive Fibryga right away upon arrival in the ED, and another group will receive the current standard of care, which typically means administering a fibrinogen-rich blood product called cryoprecipitate at a later stage of treatment, such as in surgery or intensive care.
Ginde, Douin, and their collaborators will assess how well blood clotting improves, as well as how many blood transfusions patients need after receiving Fibryga. They’ll also assess survival rates, time spent in the hospital, and side effects.
If the EFFECT trial is successful, Ginde says, “we would be able to reduce the amount of blood products transfused, and then, hopefully, improve the recovery and survival of patients as well.”
He notes that blood products from a blood bank need special storage, and some must be kept frozen and thawed before they can be used. By contrast, Fibryga is supplied as a powder that is mixed with sterile water before it’s infused. It can be stored at room temperature and prepared within minutes, which makes it easier to have ready when patients need treatment quickly. “So it has a lot of logistical advantages for both civilian and military applications,” Ginde says.
Ginde notes that Fibryga has been studied in clinical trials and used in many patients worldwide. In this study, participants will be closely monitored, as Fibryga — like all medicines made from plasma — can sometimes cause allergic reactions or blood clots.
The EFFECT study will be overseen by the DEM’s Airway, Trauma, Lung Injury, and Sepsis (ATLAS) Research Program, which Ginde leads. ATLAS focuses on clinical trials and real-world data studies in the acute care setting with a particular focus on early interventions for critically ill and injured patients.
Ginde notes that the trial’s results could be “critically important” to military health care, particularly because it points to a potential way to more rapidly and efficiently care for wounded service members. So the CU Center for Combat Medicine and Battlefield (COMBAT) Research is also involved in the trial.
The DEM and COMBAT Center’s “reputation and relationships” helped the EFFECT trial to come together and paved the way for the Octapharma grant, Ginde says.
“About a year ago, Octapharma made quite a splash with the military because they have a freeze-dried plasma product that was approved under emergency-use authorization for battlefield trauma,” he says. “They became aware of our track record of success in executing acute and critical care trials, including in trauma, and we started talking about potential partnerships on clinical trials.”
The CU and Octapharma teams proposed the Fibryga trial as a first step in what could prove to be an ongoing partnership.
“This is an investigator-initiated trial,” Ginde says. “The science, design, data collection, and dissemination are coming from our team.” But he adds that the CU researchers are also partnering with Octapharma’s “fantastic team of scientists. We’re meeting regularly. We’re talking about our ideas and we’re hearing them out on their ideas. We work together. They’re experts on their own product, so this is truly a collaboration.”
If the EFFECT trial proves successful, Ginde says, “we can immediately scale up and make this available to a large number of trauma patients around the country and around the world. That’s the beauty of academic-industry partnerships.”
Ginde credits CU Innovations, which helps foster business partnerships at the university, for its role. Key additional contributors on the EFFECT trial are data coordinating lead Tianjing Li, PhD, professor of ophthalmology; statistical coordinating lead Alex Kaizer, PhD, associate professor in the Colorado School of Public Health; and Vik Bebarta, MD (U.S. Air Force Colonel Reserve), professor and interim chair of DEM and director of the CU Center for COMBAT Research.
At a time when Ginde is taking on new clinical research leadership roles at CU Anschutz, he says this major collaboration with an industry partner on a study is “a big deal in terms of demonstrating what we’re trying to accomplish – have good scientific ideas, develop partnerships with industry and government, and then be able to execute on the work and make a big impact on health.”
Adds Douin: “Our team of trauma surgeons, emergency medicine physicians, and anesthesiologists, here at CU and around the country, are incredibly excited about the potential to improve the lives of injured patients.”