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

March 18, 2020 updated by: Jesus Reyes, National Heart Institute, Mexico

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

1425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Tlalpan
      • Mexico City, Tlalpan, Mexico, 14080
        • Recruiting
        • National Heart Institute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Patent hemostasis with TR BAND
Experimental: 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.
Patent hemostasis protocol plus ipsilateral ulnar compression
Experimental: 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.
StatSeal disc plus TR Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radial artery occlusion (RAO) according to hemostatic technique at 24 hrs and evaluate change at 30 days
Time Frame: 24 Hours and 30 days

2 Items.

  • RAO at 24 hrs
  • RAO at 30 days

Measured with Barbeau test.

24 Hours and 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular Complications
Time Frame: 30 days

1. 2 items

  • Radial arteriovenous fistula
  • Radial pseudoaneurysm
30 days
Hemorrhagic Complications
Time Frame: 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
24 hours
Radial artery occlusion according to heparin dose
Time Frame: 30 days

1. 3 items

  • RAO with < 5000 Ui heparin dose
  • RAO with 5000-8000 Ui heparin dose
  • RAO with > 8000 heparin dose
30 days
Radial artery occlusion according to sheath size
Time Frame: 30 days

1. 3 items

  • RAO with 5 Fr Sheath's
  • RAO with 6 Fr Sheath's
  • RAO with 7 Fr Sheath´s
30 days
Time to TR Band removal
Time Frame: 300 Minutes

1. 1 Item

- Averaged time until TR band removal

300 Minutes
Radial artery occlusion according to type of procedure
Time Frame: 30 days

1. 2 items

  • RAO in diagnostic procedures
  • RAO in therapeutic procedures
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Guering Eid-Lidt, MD, National Heart Institute, Mexico
  • Study Chair: Marco A Peña, MD, National Heart Institute, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

August 30, 2020

Study Completion (Anticipated)

October 30, 2020

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

June 13, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The individual patient data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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