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

NCT07646964 | Not Yet Recruiting

• 1 other identifier: MUG-STABLEEMS-2026-01
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Blood Product Stability

Keywords

Prehospital Care; Drug Storage; Temperature Monitoring; Fibrinogen Concentrate; Lyophilized Plasma; Coagulation Products

Outcome Measures

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.

  Baseline to 3 months

Secondary Outcomes (3)

• Frequency of Temperature Excursions Outside Recommended Storage Conditions

  Continuously monitored from baseline to 3 months

• Maximum and Minimum Storage Temperatures

  Baseline to 3 months

• Compliance With Manufacturer-Recommended Storage Conditions

  Continuously monitored from baseline to 3 months

Study Arms (2)

Fibryga

Human fibrinogen concentrate samples stored under routine operating conditions in a ground-based EMS ambulance and analyzed longitudinally during the study period.

Octaplas LG AB

Lyophilized human plasma samples stored under routine operating conditions in a ground-based EMS ambulance and analyzed longitudinally during the study period.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

no study population

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.

Sponsors & Collaborators

• Medical University of Graz: lead

Related Publications (2)

• Pietsch U, Moeckel J, Koppenberg J, Josi D, Jungwirth A, Hautz WE, Wenzel V, Strecke S, Albrecht R. Stability of Drugs Stored in Helicopters for Use by Emergency Medical Services: A Prospective Observational Study. Ann Emerg Med. 2022 Oct;80(4):364-370. doi: 10.1016/j.annemergmed.2022.05.038. Epub 2022 Aug 1.

  PMID: 35927113 BACKGROUND

• Helm M, Castner T, Lampl L. Environmental temperature stress on drugs in prehospital emergency medical service. Acta Anaesthesiol Scand. 2003 Apr;47(4):425-9. doi: 10.1034/j.1399-6576.2003.00062.x.

  PMID: 12694141 BACKGROUND

Central Study Contacts

Maximilian Niederer, MD

CONTACT

0316385081237; maximilian.niederer@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06