Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures (ACCESS-III)

Randomised Comparison of Oximetry Guided Deflation Versus Traditional Rapid Deflation When Removing the TR-band After Radial Angiography or Angioplasty The Access-III Study

After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO).

The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.

Study Overview

• Status: Completed
• Conditions: Radial Artery
• Intervention / Treatment: Procedure: Oximetry guided deflation

Detailed Description

3600 patients are randomized 1:1 to a traditional rapid deflation technique (Group A) versus an oximetry guided rapid deflation technique (Group B).

Before randomisation between the two deflation techniques French size of the sheath is chosen. If the operator has a preference for the size of the sheath then this size is used (5F/6F, estimated N=1200). If the operator has no preference for the size of the sheath then patients are randomized between 5 and 6 French sheath (N=2400).

Randomization between traditional rapid deflation technique (Group A) versus oximetry guided rapid deflation technique (Group B) is then stratified according to French size of the sheath used (5 French, 6 French). Terumo Glidesheath Slender is routinely used in both arms.

Assuming that the incidence of RAO (Barbeau type D, see below) can be reduced from 1.5% to 0.5% a total of 1547 patients are needed in each group if using an alfa=0.05 and beta 0.80. Assuming that the incidence of RAO or subocclusion (Barbeau type C or D, see below) can be reduced from 4% to 2% a total of 1141 patients are needed in each group to document this difference if using an alfa=0.05 and beta 0.80. The investigators plan to randomize 1800 in each group comparing oximetry guided rapid deflation with traditional rapid deflation. Assuming that the time from sheath removal to transradial-band (TR-band) removal (hemostasis) is 125 minutes with the traditional rapid deflation technique, and 110 minutes with the oximetry guided deflation technique, and the standard deviation is 60 minutes, then a total number of 253 patients are needed in each group to document a possible difference.

Data are analyzed by the intention-to-treat principle.

4-5 centres are expected to include patients.

Oral and written informed consent is collected at the ward or in the Cath.lab. The informed consent is signed before intervention.

Included patient can withdraw their assignment from the study at any time without consequence

• Study Type: Interventional
• Enrollment (Actual): 3600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of cardiology, Aarhus University Hospital in Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are scheduled for radial angiography or angioplasty.
• Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B).
• Age > 18 years.
• Patients able to cooperate and understand information given by the hospital staff.

Exclusion Criteria:

• Patients not able to give informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Traditional rapid deflation; Group A: At time of sheath removal 15 ml. air is inflated in the TR-band. The sheath is removed. Air is deflated until bleeding, and 1-2 ml. air is then re-inflated to achieve hemostasis, and the volume air inflated is registered ("Initial inflated air volume"). Every 20 minutes 1/3 of the initial inflated air volume is deflated. If bleeding occurs then air is re-inflated until hemostasis and then additional 1-2 ml. air is inflated. This routine is repeated until hemostasis is achieved (TR-band fully deflated without bleeding).
EXPERIMENTAL: Oximetry guided deflation; Group B: Initial step with sheath removal as in group A. Before departure from the cath.lab. a "Patent hemostasis test" (see description in "Interventions" below) is performed. Further action as described in "Interventions" below.	Procedure: Oximetry guided deflation; At the cath.lab. (Step 1) a hemostasis test is performed: oxymetry device on the thumb, compress a.ulnaris, evaluate if curve on device (="Patent hemostasis"). If patent no further action. If not patent, air is deflated until a.radialis is patent (curve on device and no bleeding). If bleeding occurs before patency then re-inflate 1-2 ml. air until hemostasis (="no patent hemostasis"). In patients with "Patent hemostasis" no action is taken in sixty minutes whereafter the TR-band is fully deflated (Step 2), and if bleeding then air is re-inflated until hemostasis and step 2 is repeated every 20 minutes until the TR-band is fully deflated with hemostasis. If "no patent hemostasis" at cath.lab. a hemostasis test is performed after 20 min. If "patent hemostasis" is achieved no action is taken in sixy minutes (as above). If still "not patent" then further action as in group A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAO (Reverse Barbeau type D) during index hospitalisation	The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.	Day 1 (Evaluated at time of TR-band removal)
Time from sheath removal to removal of the TR-band	The time period will be recorded in the cath. lab. and in the ward.	Day 1
Proportion who have the TR-band removed within 90,120 and 180 minutes	Calculated with STATA, statistical software	Day 1
RAO (Reverse Barbeau type D) at follow-up	The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery.	After 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAO or subocclusion during index hospitalisation	Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion.	Day 1 (Evaluated at time of TR-band removal)
Hematoma > 2.5 cm	Development of hematoma is monitored at the ward at time of discharge.	Day 1 (Evaluated at time of discharge)
Time from sheath removal to discharge	The discharge time is recorded in the patient file	Day 1
Discomfort in the arm	The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")	At 1 month and 3 months
RAO or subocclusion at follow-up	Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion.	At 1 month

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Terumo Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2018
• Primary Completion (ACTUAL): December 10, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Coronary angiography; Percutaneous coronary intervention; Radial artery occlusion; Haemostasis; Trans radial band
• Other Study ID Numbers: 1-10-72-159-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No