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临床试验/NCT03298126
NCT03298126已完成不适用

Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion

Aga Khan University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年2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
100
试验地点
2
主要终点
Radial artery occlusion (RAO)

研究概览

简要总结

Coronary artery disease (CAD) is one of the major health concerns among other non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to determine the extent of disease in coronary arteries due to atherosclerosis. Among the two approaches for cardiac catheterization, trans-radial approach has gained more popularity than conventional trans-femoral approach over the past decade with availability of compression devices for radial artery that assures lesser risk of bleeding and hematoma and has translated into increased patient comfort and early mobility post procedure. Radial artery occlusion is a common complication of trans-radial procedures often ignored by the operator after procedure due to dual blood supply by ulnar artery. Although clinically silent usually, it necessitate the need of monitoring radial artery for patency because of risk of limited trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. , compression devices applied after sheath removal may be a contributing factor to radial artery occlusion because of selective pressure for extended time duration (3-4 hours). Various protocols have been developed to remove TR band by different institutions across the globe and have been tested to assess post procedure complications. To the best of what we know, there exists no standard protocol to deflate TR band. Also, the current protocol in practice at our institution has not been evaluated against other protocols that are followed in other institution across the globe claiming lesser post procedure complications. Hence, our aim was to test through a randomized trial whether our hospital standard protocol is non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser complication rate

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Randomization was carried out after written informed consent through SNOSE (Sequentially Numbered Opaque Sealed Envelopes) method to ensure allocation concealment. Patients were randomized into two groups for TR band removal i.e. Group 1 received protocol A which is currently in practice at AKUH and group 2 underwent protocol B developed by Cohen and Alfonso which is supported by literature. The techniques for protocol A and protocol B. Radial artery patency was determined at 24 hours by a trained resident doctor who was blinded to the protocol administered.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted for coronary angiography in specified period of study
  • patients who sign informed consent

排除标准

  • known radial artery occlusion
  • > 3 radial angiograms in the past
  • plan for AD- hoc PCI
  • on warfarin therapy
  • known bleeding diathesis or hypercoagulable state
  • contraindication to radial artery access such as hemodialysis fistula, mastectomy or localized infection

研究组 & 干预措施

TR BAND Protocol A

Active Comparator

In this group, air removal from TR band was initiated after 2 hours of TR band application. 3 ml of air was removed periodically at an interval of 15 minutes until all the air is eliminated from the band. In case of bleeding or hematoma while deflating air, 4 ml of air was re-injected and observed for 30 minutes until next attempt was made to deflate the band. The data including the attempts made at deflating TR band, time and amount of air injected along with the response to each deflation i.e. occurrence of bleeding or hematoma was noted down in the proforma

干预措施: TR BAND removal protocol (Procedure)

TR BAND PROTOCOL B

Active Comparator

In this group deflation was initiated after 2 hours of TR band application as described by Cohen and Alfonso. [6] 5 ml of air was deflated at first attempt. Next attempt was carried out after 15 minutes in which further 5 ml was removed. After 15 minutes, the remaining 2 ml of air was released from the band. In case of bleeding or hematoma at any attempt, 6 ml air was re-injected and interval for 15 minutes taken to attempt further air deflation. All the attempts and its response were recorded in the proforma filled out by the assessor.

干预措施: TR BAND removal protocol (Procedure)

结局指标

主要结局

Radial artery occlusion (RAO)

时间窗: from TR band removal upto 24 hours of hospital stay of the patient

Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms

次要结局

  • Hematoma(from TR band removal upto 24 hours of hospital stay of the patient)
  • Re bleed(from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient)

研究者

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

Nasir Rahman

Assisstant Professor

Aga Khan University

研究点 (2)

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