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NOT YET RECRUITING
NCT07646964

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

Sponsor: Medical University of Graz

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

2

Start Date

2026-07-01

Completion Date

2026-11-30

Last Updated

2026-06-15

Healthy Volunteers

Not specified