Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department

Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC). This is a condition where the blood doesn't clot properly, making bleeding worse. The reasons behind TIC are complicated and not fully understood. One important substance involved is fibrinogen, a protein that helps blood clot. Low levels of fibrinogen are often the first sign of TIC and tend to be linked with how bad the injury is. Because of this, doctors have been giving trauma patients extra fibrinogen early on, hoping it will help them survive. However, a recent large study (called CRYOSTAT-2) showed that giving high doses of fibrinogen to all trauma patients didn't actually help reduce deaths. This suggests that not everyone needs it-only patients with very low fibrinogen levels (below 1.5 grams per liter) should get it. The problem is: it currently takes 30 to 45 minutes to get fibrinogen test results. In emergency situations, that's too slow. So doctors have been guessing who needs it, which might not always be the best approach. What This Study Aims to Do This new study wants to see if a faster, bedside test-called a point-of-care (POC) fibrinogen test-can be used in the Emergency Department (ED) during trauma resuscitations. Main Goals: Feasibility: Can the test be done quickly and easily during emergency care? Usefulness: If the fast test had been available, would doctors have made different decisions-like giving or not giving fibrinogen? And would that have changed outcomes for the patients? Study Details Feasibility Study: To see if the test is practical during trauma care. Retrospective Cohort Study: To look back at patients and see if early test results could have changed decisions or outcomes. Who's In the Study? Adults over 16 who arrive at the ED with serious trauma and for whom the hospital's Massive Transfusion Protocol was activated (meaning they had major bleeding). They must have received at least one unit of blood. How the Study Will Work The Test: A small amount of blood (0.15 ml) will be taken from blood that's already being drawn for routine care-so no extra blood draws are needed. The POC test (called qLabs Fib) will be done at the same time as standard lab tests. Important Note: Doctors won't make decisions based on this fast test for now. It's just being tested for feasibility. Nurses will note how long the test takes and if they had any trouble using it. Later, researchers will look back at the data to see: * What the fibrinogen levels were. * Whether the fast results could have helped guide better treatment. * If outcomes like how much blood was given or survival were affected. Why It Matters If the fast test works well, it could lead to * Faster, more accurate treatment in trauma cases. * Less unnecessary use of fibrinogen, saving resources and avoiding possible side effects. * Better outcomes for patients by tailoring treatment to their actual needs.

NCT Number	NCT07097337
Lead Sponsor	Erasmus Medical Center Collaborators: Diagnostica Stago R&D
Conditions	Trauma Induced Coagulopathy, Trauma Coagulopathy, Fibrinogen Deficiency, Fibrinogen; Deficiency, Acquired, Massive Transfusion Protocol, Massive Hemorrhage
Enrollment	150 participants
Start Date	2025-11-01
Primary Completion	2027-03-01 (estimated)
Study Completion	2027-03-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-10