Skallsjö G, Wikman A, Wessman C, Sandström G
Helicopter Emergency Medical Service, Västra Götalandsregionen, Gothenburg, Sweden.
Department of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Acta Anaesthesiol Scand. 2025 Oct;69(9):e70120. doi: 10.1111/aas.70120.
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).
大出血仍然是院前护理中最可预防的早期死亡原因之一。虽然院前输注血浆已显示出改善生存率的潜力，但后勤方面的挑战限制了其在医院外的使用。冻干血浆提供了一种切实可行的解决方案，特别是在农村或偏远地区。本统计分析方案（SAP）描述了评估冻干血浆与标准护理对院前治疗的出血患者疗效的预定义方法。
这项前瞻性、随机平行试验已在ClinicalTrials.gov（NCT07012863）注册，纳入疑似出血且需要液体复苏的成年患者（≥18岁）。救护车随机分配携带冻干血浆或标准护理（晶体液），并按城乡地区分层。每次任务后，每辆救护车将重新分配为标准护理或冻干血浆。主要结局是24小时生存率。次要结局包括凝血病标志物、输血量和运输时间的影响。所有分析均遵循意向性分析原则，并采用Cox回归、线性或分位数回归，采用Bonferroni-Holm法进行多重性调整。该试验将共纳入650例患者。
本统计分析方案确保了一项针对急需适合现场使用的血液制品的试验的透明度，并防止分析偏倚。研究结果可能为 civilian 和 military 院前护理的实践和政策提供参考。
clinicaltrials.gov（NCT07012863）。
