Prehospital Treatment With Dried Plasma in Patients With Major Bleeding—A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol
Study context
- Population
- Adults (≥ 18 years) with suspected bleeding requiring fluid resuscitation in the prehospital settingplanned enrolment
- Participants
- 650 adults
- Planned comparison
- Dried plasma vs standard care
- Primary endpoint
- Survival
- Follow-up
- 24 h
Methodological detailsprospective, parallel, multicentre, cluster (ambulance vehicles randomised, reassigned after each mission), stratified by urban and rural regions, intention-to-treat, Bonferroni-Holm adjustment for multiplicity, Analyses: Cox regression, linear or quantile regression, Secondary outcomes: markers of coagulopathy, transfusion volume, impact of transport time
- Prospective
- Parallel
- Multicentre
- Cluster (ambulance vehicles randomised, reassigned after each mission)
- Stratified by urban and rural regions
- Intention-to-treat
- Bonferroni-Holm adjustment for multiplicity
- Analyses: Cox regression, linear or quantile regression
- Secondary outcomes: markers of coagulopathy, transfusion volume, impact of transport time
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Prehospital Treatment With Dried Plasma in Patients With Major Bleeding—A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol. Acta Anaesthesiol Scand. Published 5 September 2025. doi:10.
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