NCT07097337 Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
| NCT ID | NCT07097337 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Trauma Induced Coagulopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2025-11-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria detailed below. Inclusion criteria To be eligible to participate in this study, a subject must meet the following criteria: * The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury * The participant is deemed by the attending clinician to have on-going active hemorrhage * The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated Exclusion criteria * A potential subject who meets any of the following criteria will be excluded from participation in this study: * The participant has been transferred from another hospital * The trauma team leader deems the injuries incompatible with life
Contact & Investigator
Caroline van der Marel, MD, PhD
STUDY DIRECTOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT07097337 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Trauma Induced Coagulopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07097337 currently recruiting?
Yes, NCT07097337 is actively recruiting participants. Contact the research team at n.ottenhof@erasmusmc.nl for enrollment information.
Where is the NCT07097337 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07097337 clinical trial?
NCT07097337 is sponsored by Erasmus Medical Center. The principal investigator is Caroline van der Marel, MD, PhD at Erasmus Medical Center. The trial plans to enroll 150 participants.