Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention

Not Applicable

• Conditions: Radial Artery Injury; Occlusion of Artery; Complication

• Registration Number: NCT03558243
• Lead Sponsor: National Heart Institute, Mexico

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-06-13
• Study First Posted: 2018-06-15
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-19
• Primary Completion: 2020-08-30
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1425

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days	24 Hours and 30 days	2 Items.; * RAO at 24 hrs; * RAO at 30 days; Measured with Barbeau test.

Secondary Outcome Measures

Name	Time	Method
Radial artery occlusion according to type of procedure	30 days	1. 2 items; * RAO in diagnostic procedures; * RAO in therapeutic procedures
Vascular Complications	30 days	1. 2 items; * Radial arteriovenous fistula; * Radial pseudoaneurysm
Hemorrhagic Complications	24 hours	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 to TR Band removal	300 Minutes	1. 1 Item; - Averaged time until TR band removal
Radial artery occlusion according to sheath size	30 days	1. 3 items; * RAO with 5 Fr Sheath's; * RAO with 6 Fr Sheath's; * RAO with 7 Fr Sheath´s
Radial artery occlusion according to heparin dose	30 days	1. 3 items; * RAO with \< 5000 Ui heparin dose; * RAO with 5000-8000 Ui heparin dose; * RAO with \> 8000 heparin dose

Trial Locations

Locations (1)

National Heart Institute; 🇲🇽 Mexico City, Tlalpan, Mexico