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临床试验/NCT05263765
NCT05263765Enrolling By Invitation不适用

Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA)

Methodist Health System1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月29日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Demographics-Height

研究概览

简要总结

Aortic occlusion (AO) for trauma has traditionally been accomplished by supra-diaphragmatic clamping of the descending thoracic aorta via emergent thoracotomy or as an initial step during laparotomy.

详细描述

An evolution in endovascular technologies, however, has provided additional means by which to achieve AO. Expanding experience with the utilization of balloon occlusion in the setting of abdominal aortic rupture due to chronic vascular disease has demonstrated the potential of these new technologies. Discussion of the employment of endovascular AO in the realm of trauma has led to the description of this approach and the demonstration of its effectiveness in animal models of severe hemorrhage.

The purpose of the present study is to prospectively examine the modern utilization of AO in the acute resuscitation of trauma and acute care surgery patients in shock.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult (age ≥ 18 years) trauma and acute care surgery patients treated with resuscitative AO (via open or endovascular means) in the acute phases after injury
  • Transient or refractory hypotension (systolic blood pressure <90mmHg) with a positive abdominal focused abdominal sonography in trauma (FAST) scan, severe pelvic fracture(s), or neither with persistent hypotension without obvious source
  • Chest x-ray without evidence of thoracic aortic injury
  • Subject treatment includes internal aortic cross-clamp or would have likely benefited from an internal aortic cross-clamp

排除标准

  • Subject < 18 years of age
  • Evidence of cardiac, thoracic aortic, or great vessel injury identified in primary survey, FAST scan, and/or x-rays
  • Any open/exsanguinating upper extremity wound

结局指标

主要结局

Demographics-Height

时间窗: 01 July 2015 through 31st December 2024

Height measured in Inches

Demographics- Weight

时间窗: 01 July 2015 through 31st December 2024

Weight measured in pounds

Demographics- Gender

时间窗: 01 July 2015 through 31st December 2024

Male or Female

Demographics

时间窗: 01 July 2015 through 31st December 2024

Age in years

Injury Mechanism Type

时间窗: 01 July 2015 through 31st December 2024

Gunshot wound, Motor vehicle accident, stab wound, fall

Body Region

时间窗: 01 July 2015 through 31st December 2024

Head/Neck, Chest, Abdomen, pelvis or Extremities

Injury Data

时间窗: 01 July 2015 through 31st December 2024

Mechanism classification - Penetrating, Blunt or Non-trauma Hemorrhage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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