Clinical trial NCT03558243: Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Intervention
Official title: Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Occlusion of Artery
Radial Artery Injury
Complication
Keywords: radial artery occlusion
prevention
patent hemostasis
transradial intervention
ulnar compression
Lead sponsor: National Heart Institute, Mexico
Sponsor class: OTHER_GOV
First posted: 2018-06-15
Enrollment: 1425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days
timeFrame: 24 Hours and 30 days
Secondary outcomes:
measure: Vascular Complications
timeFrame: 30 days
measure: Hemorrhagic Complications
timeFrame: 24 hours
measure: Radial artery occlusion according to heparin dose
timeFrame: 30 days
measure: Radial artery occlusion according to sheath size
timeFrame: 30 days
measure: Time to TR Band removal
timeFrame: 300 Minutes
measure: Radial artery occlusion according to type of procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Heart Institute
state: Tlalpan
Study officials:
affiliation: National Heart Institute, Mexico
name: Guering Eid-Lidt, MD
role: STUDY_DIRECTOR
affiliation: National Heart Institute, Mexico
name: Marco A Peña, MD
role: STUDY_CHAIR
References: