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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-10-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Occlusion of Artery Radial Artery Injury Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Patent Hemostasis Arm

The TR Band (Terumo medical) will be placed on the sheath entry site, the air bladder of the TR Band will be filled with 18 mL of air to achieve initial hemostasis. The sheath will be removed, air will be withdrawn slowly until a pulsatile bleeding is observed through the sheath's orifice, once this phenomenon occurs, 2 ml of air will be added to the air bladder and the absence of bleeding will be corroborated, immediately afterwards a pulse oximeter will be placed on the index finger of the patient and transient manual compression of the ipsilateral ulnar artery will be performed, patency of the radial artery will be corroborated by means of oxygen saturation and adequate pulse curve (Barbeau reverse test), if it is not possible to achieve patent hemostasis, it will be retried deflating 1-2 ml of the TR Band every 15 minutes until a positive reverse Barbeau test with absence of bleeding is achieved. TR Band removal will be attempted 2 hours after the procedure.

Group Type ACTIVE_COMPARATOR

Patent Hemostasis arm

Intervention Type PROCEDURE

Patent hemostasis with TR BAND

ULTRA Arm

The TR Band will be placed at the sheath entry site, the ipsilateral ulnar artery will be compressed at the Guyon's canal by placing a cylindrical composite made by wrapping 4 inch x 4 inch gauze around a 1-inch plastic needle cap, and compressing it using a circumferentially applied Hemoband. After occlusive compression of ulnar artery is confirmed by means of plethysmography, patent hemostasis protocol will be used for radial artery hemostasis as described at the patent hemostasis arm. The needle cap and hemoband that compresses the ulnar artery will be removed 1 hour after the procedure. TR Band removal will be attempted 2 hours after the procedure.

Group Type EXPERIMENTAL

ULTRA arm

Intervention Type PROCEDURE

Patent hemostasis protocol plus ipsilateral ulnar compression

Hemostatic Disc Arm

The StatSeal hemostatic disc will be placed above sheath entry site, the TR Band will be placed above the disc, according to the manufacturer's specifications the air bladder will be filled with 8 ml of air, the sheath will be then removed, corroborating the absence of bleeding, 20 minutes later 3 ml of air will be removed, 20 minutes after that 5 ml of air will be removed, finally the investigators will try to remove the deflated TR Band 60 minutes after the procedure.

Group Type EXPERIMENTAL

Hemostatic disc arm

Intervention Type DEVICE

StatSeal disc plus TR Band

Interventions

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Patent Hemostasis arm

Patent hemostasis with TR BAND

Intervention Type PROCEDURE

ULTRA arm

Patent hemostasis protocol plus ipsilateral ulnar compression

Intervention Type PROCEDURE

Hemostatic disc arm

StatSeal disc plus TR Band

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No