跳至主要内容
临床试验/NCT05224635
NCT05224635Enrolling By Invitation不适用

The PROspective Observational Vascular Injury Trial (PROOVIT)

Methodist Health System2 个研究点 分布在 1 个国家目标入组 5,718 人开始时间: 2021年12月30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
5,718
试验地点
2
主要终点
establish an aggregate database

研究概览

简要总结

Evidence suggests that the rate of treatable vascular injury is increasing due to improved pre-hospital strategies. The increased rate of vascular trauma occurs in an era of increased sub-specialization, shifting training paradigms and the emergence of endovascular therapies. These factors, in combination with the baseline complexity of vascular trauma, make it particularly important that the management of this injury pattern be evidence-based. However, because all forms and distributions of vascular injury represent only 4% to 9% of trauma admissions, meaningful study of one injury pattern, patient population, therapeutic or surveillance strategy is difficult at a single institution. Further complicating such efforts is the fact that vascular trauma is managed by a wide range of surgical and now endovascular specialists, further fragmenting even a busy trauma institution's experience with vascular injury.

详细描述

Several institutions and groups have contributed important insight into the understanding of vascular injury management. However, many of the studies have been single-institution, poorly powered and retrospective. The lack of evidence-based practice is even more concerning given the devastating consequences associated with mismanaged vascular trauma. In light of the stated challenges associated with single-institution study of this injury pattern, the logical method with which to proceed is a prospective, multicenter, observational trail. To date no such registries exists which would allow the prospective aggregation of larger amounts of data pertaining to all phases of vascular trauma management.

Contemporary experience confirms that the management of vascular injury is more complicated than in the past. A multitude of new or updated diagnostic technologies including computed tomography angiography (CTA), magnetic resonance angiography (MRA), duplex and arteriography now exist and are in various degrees of vogue. A damage control approach to vascular trauma is widely championed and includes options for the use of tourniquets, temporary vascular shunts and fasciotomies. Controversies regarding the definitive management of vascular trauma abound and include the advisability of open versus endovascular treatment, decisions about the type of vascular conduit and the utility of venous injury repair lo list a few. Recommendations for surveillance after vascular trauma may include the use of duplex ultrasound or CTA to confirm long-term patency as well as choices related to the use of long-term anti-thrombotic therapy. Finally, it is not uncommon for an institution to find itself facing many of these decision points in the most challenging of all scenarios, the extremes of age including pediatric vascular injury.

研究设计

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

入排标准

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

入选标准

  • Adult trauma patients; defined by the American College of Surgeons as individuals age: ≥16 years
  • CT/CTA, duplex, angiographic or clinical/ operative diagnosis of vascular injury following trauma
  • Initial management at Methodist Dallas Medical Center

排除标准

  • Age: < 16 years
  • No diagnosis of vascular injury
  • Subject transferred from another medical facility

结局指标

主要结局

establish an aggregate database

时间窗: the 1st of November 2021 through 1st of July 2024

establish an aggregate database of information of vascular trauma measured by Injury Severity Score (ISS): (range 0-75)

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 (2)

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