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

Study acronym: STABLE-EMS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Study sites: 0 to 1 · Eligibility criteria expanded, about 9 words · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 9 words
    • Publications: details revised at 2 of 2 entries
  2. Minor Re-verified, no change to tracked fieldsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07646964
Lead Sponsor Medical University of Graz
Conditions Exanguination, Trauma Coagulopathy
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov