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临床试验/NCT02398305
NCT02398305已完成不适用

Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery

University Medical Center Groningen2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Bleeding

研究概览

简要总结

To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.

The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.

Objective of the study:

To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.

研究设计

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

  • Diagnostic coronary angiogram
  • Radial access
  • 6 French sheath

排除标准

  • Use of oral anticoagulants
  • Percutaneous coronary intervention

结局指标

主要结局

Bleeding

时间窗: 1 year

Bleeding at puncture site after deflating pressure in TR band

次要结局

  • Time to discharge, after return on nursing unit(1 year)
  • Swelling(1 year)
  • Patient comfort(1 year)

研究者

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

J.H.H. (Han) Deuling

MANP

University Medical Center Groningen

研究点 (2)

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