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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 2 (estimated) |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | September 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07646964 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
- Study coordinator: Maximilian Niederer, MD
- Email: maximilian.niederer@medunigraz.at
- Phone: 0316385081237
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Simplified Tranexamic Acid Regimen for Trauma with Hemorrhage
This trial tests a simplified TXA dosing approach to see if it safely helps adults with major trauma and significant bleeding.
-
Rapid bedside fibrinogen testing for bleeding 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.
-
Using ROTEM analysis to improve outcomes in sepsis and trauma patients
This study is testing if a special blood test can help doctors spot early signs of serious blood clotting issues in patients with sepsis or trauma to improve their treatment.
-
Empiric prehospital transfusion bundle for traumatic haemorrhagic shock
We will try giving fibrinogen, plasma, and tranexamic acid before hospital arrival to adults with suspected life‑threatening bleeding from trauma to see if outcomes and safety change.
-
Using tranexamic acid to treat traumatic bleeding with real-time monitoring
This study tests whether giving tranexamic acid in a new way, based on real-time blood monitoring, can help patients with severe trauma stop bleeding better and reduce the risk of complications.
-
Using a special tourniquet for severe abdominal bleeding in trauma patients
This study is testing a special tourniquet to see if it can help trauma patients with severe abdominal bleeding in emergency situations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.