Early Lyophilised plasma In Patients with haemorrhagic Shock (ELIPS-Trial)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- NA
研究概览
简要总结
The aim of this study is to investigate whether the early administration of lyophilized plasma in the emergency room represents a better alternative to conventional crystalloid infusion solutions for patients in hemorrhagic shock.
We hypothesize that lyophilized plasma, due to its significantly shorter application time (lyophilized plasma: 6.5 minutes; conventional plasma: approximately 30–45 minutes), its positive effects on the endothelium, and its sustained volume effect, leads to faster hemodynamic stabilization. The normalization of lactate levels (< 2 mmol/L) will be used as a surrogate parameter for this. Furthermore, we expect that the use of lyophilized plasma will significantly reduce the required amount of crystalloid infusion solutions, thereby avoiding potential side effects associated with volume overload.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older; Patient in impending or hemorrhagic shock; Definition of hemorrhagic shock in this study: Obvious or suspected blood loss Systolic arterial blood pressure ≤90 mmHg or arterial hypotension requiring vasopressor administration Serum lactate concentration ≥2 mmol/L
排除标准
- •Initial activation of the massive transfusion protocol upon the patient's arrival in the emergency room Known, IgA deficiency, Hypersensitivity to plasma, Pregnancy or breastfeeding
结局指标
主要结局
NA
NA
次要结局
未报告次要终点
研究者
Dr. med. Dominik Jenny
Scientific
Johannes Kepler University Linz