Prehospital Treatment With Dried Plasma in Patients With Major Bleeding-A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol.

Abstract

Major haemorrhage remains one of the most preventable causes of early death in prehospital care. While prehospital administration of plasma has shown potential to improve survival, logistical challenges limit its use outside hospitals. Dried plasma offers a practical solution, particularly in rural or remote environments. This statistical analysis protocol (SAP) describes the predefined methods for evaluating the effect of dried plasma versus standard care in bleeding patients treated in the prehospital setting. This prospective, randomised parallel trial is registered at ClinicalTrials.gov (NCT07012863) and includes adult patients (≥ 18 years) with suspected bleeding requiring fluid resuscitation. Ambulance vehicles are randomised to either carry dried plasma or standard care (crystalloids), stratified by urban and rural regions. Each ambulance will be reassigned to either standard care or dried plasma after each mission. The primary outcome is 24-h survival. Secondary outcomes include markers of coagulopathy, transfusion volume, and impact of transport time. All analyses follow the intention-to-treat principle and utilize Cox regression, linear or quantile regression, with Bonferroni-Holm adjustment for multiplicity. The trial will enrol a total of 650 patients. This SAP ensures transparency and prevents analytical bias in a trial that addresses an urgent need for field-appropriate blood products. The results may inform practice and policy for both civilian and military prehospital care. clinicaltrials.gov (NCT07012863).