Complication Clinical Trial
Official title:
Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography
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.
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.
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