Rapid bedside fibrinogen testing for bleeding trauma patients in the emergency department

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

This will test a rapid bedside fibrinogen test for adults with traumatic bleeding to help decide who needs fibrinogen replacement.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT07097337 on ClinicalTrials.gov

What this trial studies

Trauma patients who bleed heavily can develop low fibrinogen levels that worsen clotting, but standard laboratory fibrinogen results take 30–45 minutes. This observational study uses a point-of-care fibrinogen device in the emergency department to obtain faster fibrinogen measurements on adults with active traumatic hemorrhage. Results will be compared with standard laboratory tests and linked to clinical management such as fibrinogen supplementation during massive transfusion protocol activation. Patients are enrolled rapidly on arrival under deferred consent to capture early treatment decisions.

Who should consider this trial

Good fit: Adults (about 16 years or older) who present with traumatic injury, have ongoing active hemorrhage, and trigger the hospital's massive transfusion protocol are ideal candidates.

Not a fit: Patients with minor injuries, no active bleeding, delayed presentations after initial resuscitation, or those without low fibrinogen levels are unlikely to benefit from rapid point-of-care fibrinogen testing.

Why it matters

Potential benefit: If successful, faster fibrinogen results could allow targeted fibrinogen replacement, reduce unnecessary treatment, and improve early bleeding management.

How similar studies have performed: Several observational studies suggested benefit from fibrinogen supplementation, but the CRYOSTAT-2 randomized trial found no mortality advantage for empirical high-dose fibrinogen, and rapid point-of-care fibrinogen measurement is an emerging approach with limited large-scale validation.

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

Where this trial is running

Rotterdam, South Holland

• Erasmus Medical Center — Rotterdam, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Niki A. Ottenhof, MD, PhD — Erasmus Medical Center
• Study coordinator: Niki A. Ottenhof, MD, PhD

Conditions Trauma Induced Coagulopathy; Trauma Coagulopathy; Fibrinogen Deficiency; Fibrinogen; Deficiency, Acquired; Massive Transfusion Protocol; Massive Hemorrhage; point of care fibrinogen