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临床试验/NCT01489917
NCT01489917已完成不适用

Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis

Olivier F. Bertrand3 个研究点 分布在 3 个国家目标入组 428 人开始时间: 2009年5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
发起方
入组人数
428
试验地点
3
主要终点
Radial artery occlusion

研究概览

简要总结

The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.

详细描述

Transradial access use for coronary angiography and intervention is increasing. Its efficacy in lowering access site complications, as well as increased patient comfort, has been proven unequivocally. One of the complications of transradial access is radial artery occlusion (RAO) that occurs with a variable incidence. It is population specific, with a higher prevalence in subsets, such as women, and patient's with small radial arteries. RAO is also known to be higher at hospital discharge and radial recanalization may spontaneously occur at later times. It is usually asymptomatic. Its main adverse impact is by limiting future transradial access from that radial artery. Since most of the patient's with atherosclerotic vascular disease may undergo several invasive procedures during their lifetime, prevention of RAO is of paramount importance.

Heparinization, during the procedure, has been shown to be of benefit in lowering the incidence of RAO. Maintaining patency of the radial artery during hemostasis, has also been shown to be effective in prevention of RAO following transradial access. As maintenance of flow has potent antithrombotic effect, it is unclear whether systemic anticoagulation is still required in all cases.

In some cases, it would be preferable to avoid heparin administration prior to coronary angiography. It is currently unknown whether it would be safe to refrain from heparin administration in case of transradial catheterization and patent hemostasis technique.

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

  • •all diagnostic cardiac cath patients

排除标准

  • •warfarin therapy
  • •previous ipsilateral TRA
  • •lack of consent
  • •abnormal (type D) Barbeau test
  • •scleroderma
  • •thrombocytopenia
  • •or other contraindications to heparin

研究组 & 干预措施

Compression without adjustment

No Intervention

TR band (Terumo medical) applied. The TR band is then deflated gradually till pulsatile bleeding is observed under the transparent plastic inflatable chamber and then 1-2 cc of air is placed back in the TR band chamber to stop bleeding. The band is left in place for 2 hours and not adjusted further unless patient complained of symptoms or bleeding occurred.

Patent hemostasis & heparin

Experimental

TR-band is placed and positioned similarly to the other study arm. However, in theses cases, patency is evaluated at the time of application of the TR-band, and monitored every 15 minutes afterwards till the band is removed and hemostasis completed. After TR-band placement, if maintenance of radial artery patency is obtained, no heparin is administered and TR band is left in place for 1-hour. If radial artery patency is not maintained, a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the band is left in place for 2 hours.

干预措施: Patent hemostasis and heparin (Other)

结局指标

主要结局

Radial artery occlusion

时间窗: At 30 days after the cathlab procedure

Plethysmography, confirmed with duplex Doppler ultrasonography

次要结局

  • Radial artery occlusion(At 24 hours after the cathlab procedure)

研究者

发起方
Olivier F. Bertrand
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Olivier F. Bertrand

Project Leader Transradial Research and Education Fund

Laval University

研究点 (3)

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