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

Complication Clinical Trial

— PROTHECT  

Official title:

Prevention of Radial Artery Occlusion: Comparison of Three HEmostatiC Methods in Transradial Vascular Access for Diagnostic or Therapeutic Coronary Angiography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03558243
• Other study ID #: PT-18-075
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2020
• Source: National Heart Institute, Mexico
• Contact: Jesus E Reyes, MD
• Phone: +525555732911
• Email: jesus1912[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1425
• Est. completion date: October 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Complication
• Occlusion of Artery
• Radial Artery Injury

Intervention

Procedure:
• Patent Hemostasis arm
Patent hemostasis with TR BAND
• ULTRA arm
Patent hemostasis protocol plus ipsilateral ulnar compression

Device:
• Hemostatic disc arm
StatSeal disc plus TR Band

Locations

Country	Name	City	State
Mexico	National Heart Institute	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Heart Institute, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial 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.	24 Hours and 30 days
Secondary	Vascular Complications	1. 2 items; Radial arteriovenous fistula; Radial pseudoaneurysm	30 days
Secondary	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	24 hours
Secondary	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	30 days
Secondary	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	30 days
Secondary	Time to TR Band removal	1. 1 Item; - Averaged time until TR band removal	300 Minutes
Secondary	Radial artery occlusion according to type of procedure	1. 2 items; RAO in diagnostic procedures; RAO in therapeutic procedures	30 days