Randomised Comparison of Oximetry Guided Deflation Versus Traditional Rapid Deflation When Removing the TR-band After Radial Angiography or Angioplasty The Access-III Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,600
- 试验地点
- 2
- 主要终点
- RAO (Reverse Barbeau type D) during index hospitalisation
研究概览
简要总结
After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO).
The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.
详细描述
3600 patients are randomized 1:1 to a traditional rapid deflation technique (Group A) versus an oximetry guided rapid deflation technique (Group B).
Before randomisation between the two deflation techniques French size of the sheath is chosen. If the operator has a preference for the size of the sheath then this size is used (5F/6F, estimated N=1200). If the operator has no preference for the size of the sheath then patients are randomized between 5 and 6 French sheath (N=2400).
Randomization between traditional rapid deflation technique (Group A) versus oximetry guided rapid deflation technique (Group B) is then stratified according to French size of the sheath used (5 French, 6 French). Terumo Glidesheath Slender is routinely used in both arms.
Assuming that the incidence of RAO (Barbeau type D, see below) can be reduced from 1.5% to 0.5% a total of 1547 patients are needed in each group if using an alfa=0.05 and beta 0.80. Assuming that the incidence of RAO or subocclusion (Barbeau type C or D, see below) can be reduced from 4% to 2% a total of 1141 patients are needed in each group to document this difference if using an alfa=0.05 and beta 0.80. The investigators plan to randomize 1800 in each group comparing oximetry guided rapid deflation with traditional rapid deflation. Assuming that the time from sheath removal to transradial-band (TR-band) removal (hemostasis) is 125 minutes with the traditional rapid deflation technique, and 110 minutes with the oximetry guided deflation technique, and the standard deviation is 60 minutes, then a total number of 253 patients are needed in each group to document a possible difference.
Data are analyzed by the intention-to-treat principle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients who are scheduled for radial angiography or angioplasty.
- •Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B).
- •Age > 18 years.
- •Patients able to cooperate and understand information given by the hospital staff.
排除标准
- •Patients not able to give informed consent.
结局指标
主要结局
RAO (Reverse Barbeau type D) during index hospitalisation
时间窗: Day 1 (Evaluated at time of TR-band removal)
The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.
Proportion who have the TR-band removed within 90,120 and 180 minutes
时间窗: Day 1
Calculated with STATA, statistical software
RAO (Reverse Barbeau type D) at follow-up
时间窗: After 1 month
The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.
Time from sheath removal to removal of the TR-band
时间窗: Day 1
The time period will be recorded in the cath. lab. and in the ward.
次要结局
- RAO or subocclusion during index hospitalisation(Day 1 (Evaluated at time of TR-band removal))
- Discomfort in the arm(At 1 month and 3 months)
- Hematoma > 2.5 cm(Day 1 (Evaluated at time of discharge))
- Time from sheath removal to discharge(Day 1)
- RAO or subocclusion at follow-up(At 1 month)
研究者
Christian Juhl Terkelsen
MD, DmSc, PhD, Associate professor
Aarhus University Hospital Skejby