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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Radial Artery

Intervention / Treatment
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* Procedure: Oximetry guided deflation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional rapid deflation<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemostasis, Trans radial band, Coronary angiography, Radial artery occlusion, Percutaneous coronary intervention