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

NCT03558243 | Unknown

• 1 other identifier: PT-18-075
• Study Type: interventional
• Target: 1,425
• Locations: 1 country
• Sites: 1

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.

Conditions

Occlusion of Artery; Radial Artery Injury; Complication

Keywords

radial artery occlusion; prevention; patent hemostasis; transradial intervention; ulnar compression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Vascular Complications

  30 days

• Hemorrhagic Complications

  24 hours

• Radial artery occlusion according to heparin dose

  30 days

• Radial artery occlusion according to sheath size

  30 days

• Time to TR Band removal

  300 Minutes

Study Arms (3)

Patent Hemostasis Arm

ACTIVE COMPARATOR

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 The sheath will be removed, air will be withdrawn slowly until a pulsatile bleeding is observed through the sheath's orifice, once this phenomenon occurs, 2 ml of air will be added to the air bladder and the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.

Procedure: Patent Hemostasis arm

ULTRA Arm

EXPERIMENTAL

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.

Procedure: ULTRA arm

Hemostatic Disc Arm

EXPERIMENTAL

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.

Device: Hemostatic disc arm

Interventions

Patent Hemostasis arm PROCEDURE

Patent hemostasis with TR BAND

Patent Hemostasis Arm

ULTRA arm PROCEDURE

Patent hemostasis protocol plus ipsilateral ulnar compression

ULTRA Arm

Hemostatic disc arm DEVICE

StatSeal disc plus TR Band

Hemostatic Disc Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart Institute, Mexico: lead

Study Sites (1)

National Heart Institute

Mexico City, Tlalpan, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guering Eid-Lidt, MD

  National Heart Institute, Mexico

  STUDY DIRECTOR

• Marco A Peña, MD

  National Heart Institute, Mexico

  STUDY CHAIR

Central Study Contacts

Jesus E Reyes, MD

CONTACT

+525555732911; jesus1912@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator who will evaluate the primary end point will be blinded to which hemostatic technique the patient received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology Fellow

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 15, 2018
• Study Start: May 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: October 30, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)