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

Aarhus University Hospital Skejby

Status: Completed

Conditions: Radial Artery

Treatments: Procedure: Oximetry guided deflation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03626129

1-10-72-159-18

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

3,600 participants in 2 patient groups

Traditional rapid deflation

No Intervention group

Description:

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).

Oximetry guided deflation

Experimental group

Description:

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.

Treatment:

Procedure: Oximetry guided deflation