跳至主要内容
临床试验/NCT03558243
NCT03558243Unknown不适用

Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography

National Heart Institute, Mexico2 个研究点 分布在 1 个国家目标入组 1,425 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,425
试验地点
2
主要终点
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days

研究概览

简要总结

This study evaluates three hemostatic methods for prevention of radial artery occlusion. One third of patients will receive patent hemostasis, another third will receive patent hemostasis plus ulnar compression and the last third will receive the StatSeal hemostatic disc.

详细描述

The main complication of the transradial access is the occlusion of the radial artery, which although clinically silent in most cases, has been associated with critical hand ischemia, more importantly it limits the radial approach for future coronary interventions, and limits the use of this conduit for coronary revascularization surgery and arteriovenous fistulas.

Factors that prevent occlusion of the radial artery have been identified, including the use of several hemostatic techniques at the conclusion of cardiac catheterization.

The patent hemostasis defined as a technique that allows permeability of the radial artery and at the same time ensures the absence of bleeding was the first hemostatic method that showed a decrease in the incidence of radial artery occlusion, it is currently the quality standard for hemostasis in transradial access worldwide. Recently, the patent hemostasis plus ulnar compression was described, which proved in a randomized clinical trial to be superior to conventional patent haemostasis, decreasing the incidence of radial artery occlusion to 0.8% at 30 days. These hemostatic methods are a subject of current research worldwide. And more clinical trials are expected to confirm the superiority of patent hemostasis plus ulnar compression.

The hemostatic discs used at the beginning as an attempt to reduce the times for the hemostasis of the radial access and therefore the recovery times in units of high volume have attracted attention for their effectiveness and their low incidence of radial artery occlusion, there are few reports who place it as a potential strategy to reduce the incidence of radial artery occlusion. Its effectiveness should be validated in dedicated trials with an adequate sample size.

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
Single (Outcomes Assessor)

盲法说明

The investigator who will evaluate the primary end point will be blinded to which hemostatic technique the patient received.

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

  • Patients over 18 years of age, both genders, in whom successful transradial access is obtained for elective and urgent diagnostic or therapeutic coronary procedures.

排除标准

  • Patients over 18 years of age, both genders, in whom successful transradial access is not achieved and crossover is performed to femoral access.
  • Patients over 18 years of age, both genders, who do not give their informed consent to participate in the study.
  • Patients over 18 years, both genders, with cardiogenic shock.

结局指标

主要结局

Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days

时间窗: 24 Hours and 30 days

2 Items. * RAO at 24 hrs * RAO at 30 days Measured with Barbeau test.

次要结局

  • Radial artery occlusion according to type of procedure(30 days)
  • Vascular Complications(30 days)
  • Hemorrhagic Complications(24 hours)
  • Time to TR Band removal(300 Minutes)
  • Radial artery occlusion according to sheath size(30 days)
  • Radial artery occlusion according to heparin dose(30 days)

研究者

发起方
National Heart Institute, Mexico
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Jesus Reyes

Interventional Cardiology Fellow

National Heart Institute, Mexico

研究点 (2)

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