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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,425
Patent hemostasis with TR BAND
Patent hemostasis protocol plus ipsilateral ulnar compression
StatSeal disc plus TR Band
National Heart Institute
Mexico City, Tlalpan, Mexico
RECRUITINGRadial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days
2 Items. * RAO at 24 hrs * RAO at 30 days Measured with Barbeau test.
Time frame: 24 Hours and 30 days
Vascular Complications
1\. 2 items * Radial arteriovenous fistula * Radial pseudoaneurysm
Time frame: 30 days
Hemorrhagic Complications
1\. 2 items * Thrombolysis In Myocardial Infarction criteria, Non Coronary Artery Bypass Grafting related bleeding * Major bleeding * Minor bleeding * Minimal bleeding * Hematoma formation EASY hematoma scale * Grade 1 * Grade II * Grade III * Grade IV * Grade V
Time frame: 24 hours
Radial artery occlusion according to heparin dose
1\. 3 items * RAO with \< 5000 Ui heparin dose * RAO with 5000-8000 Ui heparin dose * RAO with \> 8000 heparin dose
Time frame: 30 days
Radial artery occlusion according to sheath size
1\. 3 items * RAO with 5 Fr Sheath's * RAO with 6 Fr Sheath's * RAO with 7 Fr Sheath´s
Time frame: 30 days
Time to TR Band removal
1\. 1 Item \- Averaged time until TR band removal
Time frame: 300 Minutes
Radial artery occlusion according to type of procedure
1\. 2 items * RAO in diagnostic procedures * RAO in therapeutic procedures
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.