Stability of Blood Clotting Products Stored in Emergency Ambulances Under Real-World Conditions (STABLE-EMS)

June 15, 2026 updated by: Medical University of Graz

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Emergency medical service (EMS) medications and blood products are routinely exposed to varying environmental conditions during storage and transport. Seasonal temperature fluctuations, prolonged vehicle operation, and environmental influences may result in deviations from manufacturer-recommended storage conditions. While several studies have demonstrated the stability of commonly used emergency medications under real-world prehospital conditions, limited evidence is available regarding the stability of blood coagulation products stored in EMS vehicles.

Human fibrinogen concentrates and lyophilized human plasma (Octaplas LG AB) are increasingly available in prehospital emergency care for the early management of severe hemorrhage and trauma. Both products are subject to specific storage requirements defined by the manufacturer. Although these products are intended to be stored under controlled conditions, maintaining recommended storage environments continuously in operational EMS vehicles may be challenging, particularly during periods of elevated ambient temperatures. Data regarding the impact of such environmental exposure on product stability in the prehospital setting remain scarce.

The objective of this prospective observational longitudinal study is to evaluate the stability of fibrinogen concentrates and Octaplas LG AB when stored under routine operating conditions in a ground-based EMS ambulance in Graz, Austria. The study will be conducted during the summer months from July through September 2026, representing the period with the highest expected thermal stress on medical products stored in emergency vehicles.

At study initiation, reference samples of both products will be retained under manufacturer-recommended storage conditions. Additional study samples will be placed in the ambulance medication storage system and exposed to routine operational conditions throughout the observation period. Laboratory analyses will be performed at predefined monthly intervals to assess potential changes in product stability over time. All analyses will be conducted at the Department of Blood Group Serology and Transfusion Medicine, Medical University of Graz, using validated laboratory methods appropriate for each product. Product-specific stability parameters will be compared with baseline and reference samples stored according to manufacturer recommendations.

Environmental conditions will be continuously monitored throughout the study period. Temperature sensors will be installed both within the medication storage containers and inside the ambulance vehicle. Measurements will be recorded automatically at 10-minute intervals over the entire observation period. These data will be used to characterize environmental exposure profiles and to quantify the frequency, magnitude, and duration of deviations from recommended storage conditions.

The primary objective is to determine whether storage under real-world prehospital operating conditions results in measurable changes in the stability of fibrinogen concentrates and Octaplas LG AB over a three-month observation period. Secondary objectives are to characterize temperature conditions within EMS medication storage systems, assess compliance with manufacturer-recommended storage conditions, quantify environmental excursions outside recommended storage ranges, evaluate potential associations between environmental exposure and laboratory measures of product stability, and describe seasonal storage conditions encountered in a ground-based EMS system.

No patients will be enrolled, and no clinical interventions will be performed as part of this study. The investigation is limited to pharmaceutical product samples and environmental monitoring within an operational EMS vehicle. Consequently, no patient-related outcomes, safety endpoints, adverse events, or clinical efficacy outcomes will be assessed.

Descriptive statistics will be used to summarize environmental and laboratory data. Continuous variables will be reported as means with standard deviations or medians with interquartile ranges, as appropriate. Longitudinal changes in laboratory stability parameters will be assessed across repeated measurements obtained during the observation period. Associations between environmental variables, including temperature and laboratory indicators of product stability will be explored using correlation analyses and regression-based approaches where appropriate. Missing measurements, if encountered, will not be imputed and will be reported transparently.

The results of this study are expected to provide evidence regarding the suitability of current EMS storage practices for blood coagulation products under routine operating conditions. The findings may contribute to future recommendations for the storage, transport, and quality assurance of coagulation products used in prehospital emergency medicine.

Study Type

Observational

Enrollment (Estimated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

no study population

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of fibrinogen concentrates and Octaplas LG AB During Storage Under Real-World EMS Conditions
Time Frame: Baseline to 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Temperature Excursions Outside Recommended Storage Conditions
Time Frame: Continuously monitored from baseline to 3 months
Number and duration of temperature measurements exceeding manufacturer-recommended storage limits for Fibryga and Octaplas LG AB during the observation period.
Continuously monitored from baseline to 3 months
Maximum and Minimum Storage Temperatures
Time Frame: Baseline to 3 months
Highest and lowest temperatures recorded within medication storage compartments and inside the ambulance vehicle during the study period.
Baseline to 3 months
Compliance With Manufacturer-Recommended Storage Conditions
Time Frame: Continuously monitored from baseline to 3 months
Percentage of recorded measurements within the recommended storage conditions specified by the manufacturers of Fibryga and Octaplas LG AB.
Continuously monitored from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MUG-STABLEEMS-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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