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

NCT07097337 | Recruiting

• 1 other identifier: POCFIB
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma Induced Coagulopathy; Trauma Coagulopathy; Fibrinogen Deficiency; Fibrinogen; Deficiency, Acquired; Massive Transfusion Protocol; Massive Hemorrhage

Keywords

point of care fibrinogen; trauma induced coagulopathy; fibrinogen suppletion; fibrinogen

Outcome Measures

Primary Outcomes (1)

• Feasibility of qLabs Fib testing in the emergency department

  Feasibility of qLabs Fib testing in the ED, where feasibility will be determined by percentage of qLabs Fib results available within 30min after patient arrival in the ED.

  2 hours after inclusion

Secondary Outcomes (9)

• Incidents during testing

  2 hours after inclusion

• Total number of transfusion products uses

  24 hours

• 6hr, 24hr and 30d mortality

  30 days

• Coagulation measurements in the first 24hrs

  24 hours

• Trauma mechanism

  2 hours after inclusion

Study Arms (1)

Trauma patients for which the massive transfusion protocol is activated and transfusion is initiated

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All trauma patients for which the massive transfusion protocol has been activated and transfusion has been initiated.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Diagnostica Stago R&D: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Related Publications (1)

• White NJ. Mechanisms of trauma-induced coagulopathy. Hematology Am Soc Hematol Educ Program. 2013;2013:660-3. doi: 10.1182/asheducation-2013.1.660.

  PMID: 24319248 BACKGROUND

MeSH Terms

Conditions

Afibrinogenemia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Caroline van der Marel, MD, PhD

  Erasmus Medical Center

  STUDY DIRECTOR

• Niki A. Ottenhof, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niki A. Ottenhof, MD, PhD

CONTACT

+31-10-70-41277; n.ottenhof@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 31, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)