Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedical University of Graz
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
no study population
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2 Participants
are grouped into 2 trial groupsGroup A: Fibrinogen conentrate
Group B: Octaplas LG AB
Trial outcomes
Primary outcomes
1
Stability of fibrinogen concentrates and Octaplas LG AB During Storage Under Real-World EMS Conditions
Change in predefined laboratory stability parameters of fibrinogen concentrates and Octaplas LG AB after storage under routine operating conditions in a ground-based emergency medical service ambulance compared with baseline reference samples stored according to manufacturer recommendations.
Time frame
Baseline to 3 monthsSecondary outcomes
1
Frequency of Temperature Excursions Outside Recommended Storage Conditions
Number and duration of temperature measurements exceeding manufacturer-recommended storage limits for Fibryga and Octaplas LG AB during the observation period.
Time frame
Continuously monitored from baseline to 3 months2
Maximum and Minimum Storage Temperatures
Highest and lowest temperatures recorded within medication storage compartments and inside the ambulance vehicle during the study period.
Time frame
Baseline to 3 months3
Compliance With Manufacturer-Recommended Storage Conditions
Percentage of recorded measurements within the recommended storage conditions specified by the manufacturers of Fibryga and Octaplas LG AB.
Time frame
Continuously monitored from baseline to 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov