Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures

Radial Artery Clinical Trial

— ACCESS-III  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626129
• Other study ID #: 1-10-72-159-18
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: December 10, 2021

Study information

• Verified date: May 2022
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3600
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Radial Artery

Intervention

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.

Locations

Country	Name	City	State
Denmark	Department of cardiology, Aarhus University Hospital in Skejby	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Terumo Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	Proportion who have the TR-band removed within 90,120 and 180 minutes	Calculated with STATA, statistical software	Day 1
Primary	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	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)
Secondary	Hematoma > 2.5 cm	Development of hematoma is monitored at the ward at time of discharge.	Day 1 (Evaluated at time of discharge)
Secondary	Time from sheath removal to discharge	The discharge time is recorded in the patient file	Day 1
Secondary	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
Secondary	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