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临床试验/NCT05892367
NCT05892367已完成不适用

Transbrachial Access for Interventions in Patients With Peripheral Arterial Occlusive Disease: Evaluation of Local Complications With or Without Post-interventional Immobilization of the Upper Extremity

Wilhelminenspital Vienna2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2018年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
2
主要终点
Occurrence of local complications at the puncture site

研究概览

简要总结

The aim of the present study is an evaluation, whether an immobilization of the upper extremity by means of a positioning splint can help to reduce the incidence of local complications after transbrachial puncture for peripheral arterial interventions, or not.

详细描述

Increasing numbers of peripheral arterial interventions are performed via transbrachial access leading to a higher number of local complications at the puncture site. Patients are demonstrating complications, such as hematoma, false aneurysm, secondary hemorrhage and arterial stenosis or occlusion.

Due to not standardized post-interventional procedure regarding to immobilization a higher risk for local puncture site complication can occur. Usually, a compression bandage its applied to the brachial puncture site. Within this randomized study, patients randomized to the study group will receive an additional splint for 24 hours to ensure an immobilization of the affected arm.

Following the removal of the compression dressing, and the splint in the study group, a duplex ultrasound its performed in order to detect local alterations and pathologies of the brachial artery.

This examination is repeated for each patient in the course of an outpatient control six weeks post-interventionally. Pathologies are documented and treated if necessary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Female and male patients suffering from peripheral arterial occlusive disease with indicated interventions via an transbrachial access (puncture of the left or right brachial artery)
  • age > 18 years
  • approval to participate

排除标准

  • unability or refusal to participate
  • dialysis patients/AV-fistula interventions
  • usage of closure devices

结局指标

主要结局

Occurrence of local complications at the puncture site

时间窗: 6 weeks

Local complications as hematoma, bleeding, pseudoaneurysm, arterial dissection, arterial stenosis, arterial occlusion, AV fistula detected by ultrasound 24 hours after intervention and at time of follow-up six weeks after treatment

次要结局

  • Post-interventional pain at puncture site(24 hours)

研究者

发起方
Wilhelminenspital Vienna
申办方类型
Other
责任方
Principal Investigator
主要研究者

Edda Skrinjar, M.D.

M.D.

Wilhelminenspital Vienna

研究点 (2)

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