跳至主要内容
临床试验/NCT04760977
NCT04760977招募中不适用

Prehospital Management of Hypotensive Trauma in HEMS

Azienda Usl di Bologna15 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
15
主要终点
30 days mortality

研究概览

简要总结

Up to today, inadequate evidences and knowledge exist about the best prehospital management of hypotensive trauma patients and its clinical consequence on the in-hospital recovery and mortality.

Also new emerging therapies such as prehospital blood transfusion and REBOA (resuscitative endovascular balloon occlusion of the aorta) are lacking strong evidences in, eventually, reducing hospital mortality and improving outcomes.

Moreover, prehospital emergency medicine is throughout Italy an heterogeneous system that has no unique standard operating procedures and, even among HEMS (helicopter emergency medical service), management and therapies on complex trauma patients may vary upon local policies.

With this study we aim to enroll hypotensive trauma patients and study factors of prehospital rescue that can be associated with in-hospital mortality and recovery, eventually even with hospital outcome. For each patients data as demographic, kind of trauma (mechanism, injury scores), therapies and maneuvers will be recorded and then analyzed in comparison with in-hospital data such as need for transfusion, ABG parameters, length of stay (in-ward and ICU), need of therapies like invasive ventilation and renal replacement therapy, recovery and outcome

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Witnessed traumatic event managed by HEMS
  • Shock at first evaluation (Systolic blood pressure < 90 mmHg)
  • Suspect or obvious ongoing haemorrage

排除标准

  • Patients in cardiac arrest at HEMS arrival in which resuscitation is not started or interrupted by HEMS crew

研究组 & 干预措施

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

干预措施: Drugs administration (Drug)

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

干预措施: Resuscitative endovascular balloon occlusion of the aorta (Device)

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

干预措施: Blood transfusions (Biological)

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

干预措施: Prehospital management (Other)

Trauma patients in shock

The study focuses on hypotensive trauma patients assisted by HEMS teams

干预措施: Prehospital eFAST (Device)

结局指标

主要结局

30 days mortality

时间窗: 30 days

次要结局

  • survival from prehospital to hospital admmission(1 day)
  • Hospital length of stay(6 months)
  • Transport time(24 hours)
  • Blood products transfused during the first 24 hours after hospital admission(24 hours)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (15)

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