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临床试验/NCT03613454
NCT03613454已完成不适用

Embolization in Splenic Trauma (ELSA)

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Number of Participants Who Were Enrolled Within 18 Months of Study Initiation

研究概览

简要总结

Randomized, prospective, feasibility study to begin evaluating the efficacy, safety, and cost of using either coils or vascular plugs (VPs) for proximal splenic artery embolization in the setting of traumatic splenic injury.

详细描述

Splenic preservation rates are improved for participants with high-grade splenic injuries (defined as Grade III-V injuries by the American Association for the Surgery of Trauma (AAST) guidelines) when non-operative management is supplemented by image-guided, trans-catheter splenic artery embolization (SAE). SAE is currently the standard of care for hemodynamically stable participants with high-grade splenic injuries. In proximal SAE (pSAE), the mid-splenic artery is embolized between the origins of the dorsal pancreatic artery and pancreatica magna artery with either VPs or coils. This reduces the intra-splenic arterial pressure which allows the parenchyma time to heal. Splenic perfusion is maintained via a collateral pathway consisting of flow from the splenic artery proximal to the site of embolization through the smaller dorsal pancreatic artery to the transverse pancreatic artery to the pancreatica magna artery which then delivers a slower, smaller amount of blood to the splenic artery distal to the site of embolization. Additionally, collateral supply from the short gastric and gastroepiploic arteries helps to protect the spleen from infarction and/or abscess formation.

pSAE is most often accomplished using either coils or VPs as the embolic agent, both of which are FDA-approved and clinically-available. Coils have a long history of efficacy and safety for embolization and are thus familiar embolic agents to most endovascular specialists. Further, coils large enough to embolize the mid-splenic artery can be deployed through a standard micro-catheter, which means they can be used in even the most tortuous splenic arteries. However, multiple coils may need to be deployed in the same patient to achieve hemostasis in the mid-splenic artery that may increase their overall cost, iodinated contrast use, procedural time, and the radiation exposure to the participant and medical staff. Additionally, given the high-flow nature of the splenic artery, even an appropriately sized coil may migrate distally. A typical pSAE using coils will involve the deployment of one helical coil followed by multiple packing coils until hemostasis is achieved. VPs attempt to overcome the limitations of coils. For example, the deployment of a single VP can typically provide hemostasis in the mid-splenic artery which theoretically reduces procedural time, contrast load, and radiation exposure. Despite this, VPs are more expensive than coils on a per unit basis and are usually less familiar devices to endovascular specialists. Another drawback of VPs is that they cannot be deployed through a standard micro-catheter but rather require the advancement of a larger, stiffer 0.035 inch system into the mid-splenic artery. This may limit their use in very tortuous splenic arteries. Currently, the selection of embolic agent for pSAE is primarily based on operator experience and preference. The embolic efficacy, technical success, and cost of using coils compared to VPs has been evaluated in other diseases; yet, to the best of our knowledge, these embolic agents have never been compared for their use in pSAE, much less in a randomized, prospective fashion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Patients presenting to the University of Alabama at Birmingham (UAB) emergency room requiring embolization of the splenic artery

排除标准

  • 未提供

结局指标

主要结局

Number of Participants Who Were Enrolled Within 18 Months of Study Initiation

时间窗: Through study completion, an average of 1 year

The primary outcome of the study will be enrolling 50 participants in the study within 18 months of study initiation with adequate 30 day follow-up on all participants.

次要结局

  • Number of Participants With Embolization Success(Through study completion, an average of 1 year)
  • Number of Participants With Immediate Complications(During the embolization procedure, an average of 1 hour)
  • Number of Participants With Splenic Salvage(30 days after procedure)
  • Radiation Exposure(During the embolization procedure, an average of 1 hour)
  • Contrast Volume(During the embolization procedure, an average of 1 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrew J. Gunn

Principal Investigator

University of Alabama at Birmingham

研究点 (2)

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