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| Name | Class |
|---|---|
| Terumo Corporation | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional rapid deflation | No Intervention | 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology, Aarhus University Hospital in Skejby | Aarhus | 8200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40340123 | Derived | Aagren Nielsen CG, Rasmussen MB, Rohde PT, Jensen RV, Jakobsen L, Stottrup NB, Veien KT, Larsen EN, Charlot MG, Terkelsen CJ. Randomized comparison of sheath size for coronary intervention: time to hemostasis and risk of radial artery occlusion. Cardiovasc Revasc Med. 2026 Feb;83:59-66. doi: 10.1016/j.carrev.2025.04.042. Epub 2025 May 1. |
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| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |