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临床试验/ACTRN12611000489998
ACTRN12611000489998已完成未知

A comparison of transradial versus transfemoral and standard versus ultrasound-guided approaches in reducing bleeding rates in patients undergoing coronary angiography or angioplasty.

Dr Phong Nguyen0 个研究点目标入组 1,388 人开始时间: 2011年5月10日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
1,388

研究概览

简要总结

Abstract Aims: This study compared outcomes in unselected patients undergoing cardiac catheterization via transradial versus transfemoral access and standard versus ultrasound-guided arterial access. Methods and Results: A prospective, randomised (radial vs. femoral and standard vs. ultrasound), 2x2 factorial trial of 1388 patients undergoing coronary angiography and percutaneous coronary intervention. The primary outcome was a composite of ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) major bleeding, MACE (death, stroke, myocardial infarction or urgent target lesion revascularization) and vascular complications at 30 days. Transradial access reduced primary outcome when compared with transfemoral approach. There was no difference in the primary outcome between standard and ultrasound guidance. Ultrasound guidance however reduced mean access time, attempts, difficult accesses, venipuncture and improved first-pass success. Conclusions: Transradial access significantly reduced composite outcome compared to transfemoral access. Ultrasound guidance did not reduce primary outcome compared to standard technique, but significantly improved efficiency and overall success rate of arterial access.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • All patients over 18 years of age who present to the cardiac catheter lab

排除标准

  • 1.Cardiogenic shock or intubated patients
  • 2.Previous CABG
  • 3.Negative Allen’s test
  • 4.Known difficulties (including previous unsuccessful access) with femoral (i.e. Leriche syndrome, severe peripheral artery disease, large abdominal aortic aneurysm) or radial access (Raynaud syndrome).
  • 5.Simultaneous right heart catherisation
  • 6.Pregnant
  • 7.Haemodialysis patients with an arteriovenous fistula
  • 8.Inability to give informed consent or unable to apply with all requirements

研究者

发起方
Dr Phong Nguyen

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