Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions

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Conditions studied: Exanguination, Trauma Coagulopathy

In brief

Emergency medical service (EMS) vehicles are exposed to a wide range of environmental conditions, including high temperatures during summer months. These conditions may affect the stability and quality of medications and blood products carried for emergency treatment. This observational study aims to evaluate the stability of human fibrinogen concentrates and human plasma proteins (Octaplas) when stored under routine operating conditions in a ground-based EMS ambulance in Graz, Austria. Drug samples will be analyzed monthly over a four-month period and compared with reference samples stored under recommended conditions. In addition, temperature inside the storage containers and the vehicle will be continuously monitored. The study will assess whether prolonged exposure to real-world prehospital storage conditions affects product stability and whether any changes are associated with environmental factors. The findings may help determine whether current storage practices in EMS vehicles are adequate for maintaining the quality of these blood coagulation products.

Key facts

Study ID

NCT07646964

Run by

Medical University of Graz

People needed

2

Starts

2026-07-01

Expected to finish

2026-11-30

Last updated by the study team

2026-06-17

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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