Clinical trial Recruiting at 1 site Observational

Stability of blood clotting products in ambulances under real-world conditions

Official title: Stability of Human Fibrinogen (Fibryga) and Lyophilized Human Plasma (Octaplas LG AB) Under Real-World Prehospital Emergency Medical Service Storage Conditions: A Prospective Observational Study

Run by Medical University of Graz · NCT07646964 · Data updated 2026-11-12

This study checks whether fibrinogen concentrates and Octaplas plasma stay stable when stored in real EMS ambulances in Graz, Austria.

Quick facts

Study typeObservational
SexAll
Enrollment2 (estimated)
SponsorMedical University of Graz
Academic / other
Locations1 site (Graz)
StatusRecruiting
StartedJuly 1, 2026
Main results expectedSeptember 30, 2026
Study endsNovember 30, 2026
Registry record updatedOctober 8, 2026
Trial IDNCT07646964 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are EMS-related samples of Fibryga fibrinogen concentrate and Octaplas LG AB stored in participating Graz ambulances during routine operations.

Probably not a fit

The study does not involve patient treatment and may not imply direct benefit to any individual patient.

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

What this trial studies

This prospective observational study monitors the stability of human fibrinogen concentrates and lyophilized plasma (Octaplas) stored in ground-based EMS ambulances under routine operating conditions during summer. Samples are collected and analyzed monthly over four months and compared with reference samples kept under manufacturer-recommended conditions. Temperature inside storage containers and the vehicle is continuously tracked to identify any environmental factors linked to stability changes. The aim is to determine if common prehospital storage practices affect product quality and if current procedures should be adjusted.

Why it matters

Potential benefit: If stability is maintained, EMS storage practices may continue to support effective prehospital hemorrhage management.

How similar studies have gone: Previous work has shown mixed stability results for emergency medications under real-world conditions; this study adds data specifically for coagulation products in ambulances.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Fibryga samples stored in the participating ground-based EMS ambulance.
* Octaplas LG AB samples stored in the participating ground-based EMS ambulance.
* Samples available for laboratory analysis at the predefined study time points.
* Samples exposed to routine operational storage conditions during the study period.

Exclusion Criteria:

* Samples with damaged packaging.
* Samples with incomplete storage documentation.
* Samples accidentally removed from the designated storage system during the observation period.
* Samples unavailable for laboratory analysis.
* Samples exposed to conditions not representative of routine EMS operation.

Where it's running

  • Medical University of Graz
    Graz, Austria
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.