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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: n.ottenhof@erasmusmc.nl
• Phone: +31-10-70-41277

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Empiric prehospital transfusion bundle for traumatic haemorrhagic shock

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• Using tranexamic acid to treat traumatic bleeding with real-time monitoring

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  Recruiting Phase 4 Nanfang Hospital, Southern Medical University · Guangzhou, Guangdong · NCT06736860

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.