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临床试验/NCT04900987
NCT04900987已完成不适用

Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial

National Institute of Cardiovascular Diseases, Pakistan1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2021年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
1
主要终点
Mean of

研究概览

简要总结

The duration of radial artery compression with the use of steri-strips may become much shorter than the duration of using the conventional pneumatic TR band alone for achieving hemostasis. Consequently, the frequency of radial artery occlusion (RAO) will be much lower and post procedure patency of radial artery will be higher along with significant alleviation of pain duration.

Steri-strips is a kind of sterile adhesive tape used to approximate the clean and superficial wound or surgical incision as an alternate of stitch. Its ability to keep the radial puncture site incision approximated will lead to lesser chances of platelet plug disruption or displacement at the entry site and will hasten the process of hemostasis. The use of steri-strips unlikely to have adverse consequences as it is going to be used as an assist to the usual conventional method. In a study conducted by Faravash et al. in 2016, showed significant reduction in the area of post-rhinoplasty ecchymosis in lower lid, malar and cheek soft tissues with use of steri-strips with no reported safety concerns.

Therefore, the aim of this study is to compare duration of radial artery compression by conventional method using the pneumatic TR band alone and with use of surgical steri-strips for achieving hemostasis with patency of radial artery after transradial coronary angiography along with reduction of pain duration due to arterial compression.

详细描述

Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.

Treatment group. Pneumatic TR band compression with use of steri-strips

Control group. Pneumatic TR band compression alone

Method of radial artery compression after sheath removal:

Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.

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
否

入选标准

  • •Patients undergoing coronary angiography through transradial approach
  • •Either gender with age ≥18 years
  • •Positive Barbeau test (type A to C)

排除标准

  • •Patients refuse to give consent
  • •Negative Barbeau test (type D)
  • •Patients with bleeding diathesis or on oral anticoagulation

研究组 & 干预措施

Treatment group

Experimental

After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 to 2 hour.

干预措施: Steri-strips (Device)

Control group

No Intervention

Application of pneumatic TR band alone for 4 hours as per usual practice

结局指标

主要结局

Mean of

时间窗: Immediately after removal of TR band

Time duration of achieving hemostasis

Number of Participants with

时间窗: After 24 hour of removal of TR band

Radial artery patency

次要结局

  • Number of Participants with(Immediately after removal of TR band)

研究者

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

Kamran Ahmed Khan

Assistant Professor of Cardiology

National Institute of Cardiovascular Diseases, Pakistan

研究点 (1)

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