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Completed

NCT Number: NCT03626129

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

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.

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Key information

Conditions

Radial Artery Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oximetry guided deflation

Procedure

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.

Primary outcomes

  1. RAO (Reverse Barbeau type D) during index hospitalisation

    Time frame: Day 1 (Evaluated at time of TR-band removal)

    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.

  2. Time from sheath removal to removal of the TR-band

    Time frame: Day 1

    The time period will be recorded in the cath. lab. and in the ward.

  3. Proportion who have the TR-band removed within 90,120 and 180 minutes

    Time frame: Day 1

    Calculated with STATA, statistical software

  4. RAO (Reverse Barbeau type D) at follow-up

    Time frame: After 1 month

    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.

Secondary outcomes

  1. RAO or subocclusion during index hospitalisation

    Time frame: Day 1 (Evaluated at time of TR-band removal)

    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.

  2. Hematoma > 2.5 cm

    Time frame: Day 1 (Evaluated at time of discharge)

    Development of hematoma is monitored at the ward at time of discharge.

  3. Time from sheath removal to discharge

    Time frame: Day 1

    The discharge time is recorded in the patient file

  4. Discomfort in the arm

    Time frame: At 1 month and 3 months

    The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain")

  5. RAO or subocclusion at follow-up

    Time frame: At 1 month

    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.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Terumo Corporation

Registry information

Official study 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

Acronym: ACCESS-III

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 10, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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