Clinical trial NCT03626129: Oximetry Guided Versus Traditional Rapid Deflation Technique for Achieving Hemostasis After Radial Procedures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery
Keywords: Haemostasis
Trans radial band
Coronary angiography
Radial artery occlusion
Percutaneous coronary intervention
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
Collaborators: name: Terumo Corporation
First posted: 2018-08-10
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: RAO (Reverse Barbeau type D) during index hospitalisation
timeFrame: Day 1 (Evaluated at time of TR-band removal)
measure: Time from sheath removal to removal of the TR-band
timeFrame: Day 1
measure: Proportion who have the TR-band removed within 90,120 and 180 minutes
timeFrame: Day 1
measure: RAO (Reverse Barbeau type D) at follow-up
timeFrame: After 1 month
Secondary outcomes:
measure: RAO or subocclusion during index hospitalisation
timeFrame: Day 1 (Evaluated at time of TR-band removal)
measure: Hematoma > 2.5 cm
timeFrame: Day 1 (Evaluated at time of discharge)
measure: Time from sheath removal to discharge
timeFrame: Day 1
measure: Discomfort in the arm
timeFrame: At 1 month and 3 months
measure: RAO or subocclusion at follow-up
timeFrame: At 1 month
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital in Skejby
Study officials:
References: