CryoFIRST (Cryoprecipitate For Immediate Resuscitation in Severe Trauma) is a multicenter, pragmatic observational study examining the use of INTERCEPT Fibrinogen Complex (IFC) for the early treatment of functional hypofibrinogenemia in severely bleeding trauma patients. The study prospectively follows patients who receive IFC as part of routine clinical care and includes a retrospective comparator cohort to evaluate treatment patterns and outcomes.

CryoFIRST will assess whether having a fibrinogen-rich product readily available can increase the proportion of eligible trauma patients who receive fibrinogen replacement within 60 minutes and successfully correct functional hypofibrinogenemia. Additional outcomes include time to hemostasis, blood loss, transfusion requirements, mortality, and complications associated with severe traumatic hemorrhage.

The study is being conducted across several participating Level I trauma centers, with the R Adams Cowley Shock Trauma Center at the University of Maryland, Baltimore serving as the lead site and Deborah Stein, MD, MPH, serving as Study Principal Investigator. CryoFIRST is funded by the U.S. Department of Defense and is intended to generate real-world evidence on the feasibility and clinical impact of earlier fibrinogen replacement during trauma resuscitation.