Radial Artery Injury
Conditions
Keywords
RAO, Hemostasis, TRA
Brief summary
This study aims to demonstrate the superiority in clinical performances of a dual artery compression device (Terry-2 band) compared to a standard radial artery-only hemostasis device (HemoSTOP).
Interventions
DEVICEHemostasis
Compression device to achieve hemostasis.
Sponsors
Olivier F. Bertrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any patients referred for diagnostic angiography and possible percutaneous coronary intervention (PCI)
Exclusion criteria
* Patient unable to understand study design or objectives * Unable to sign informed consent * Patient taking warfarin or other anticoagulant therapy * Chronic RAO on both sides precluding TRA * Previous ipsilateral transradial approach * Inability to comply with the study follow-up * Presence of plethysmographic waveform with radial and ulnar occlusive compression * Pre-existing local complication (i.e. hematoma, pseudo-aneurysm, ...) precluding access-site evaluation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of RAO after transradial approach (TRA) at hospital discharge | up to 24 hours | To determine whether the use of a dual artery compression decreases the rate of radial artery occlusion after transradial catheterization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of radial artery patent-hemostasis during hemostasis | throughout intervention, up to 180 minutes | To determine the conservation of blood flow through the radial artery during compressive hemostasis |
| Patient comfort during hemostasis as assessed on a visual scale | throughout intervention, up to 30 days | To evaluate the level of patient comfort in relation to the device used |
| Rates of complications such as repeat bleeding and hematoma (EASY Scale) | throughout intervention, up to 30 days | To determine the incidence of complications in relation to the device used. Bleeding, spasm and presence of hematomas will be evaluated. |
| Nursing involvement in hemostasis management for sensitivity analysis on cost assessment | throughout intervention, up to 24 hours | To determine the overall nursing involvement (time per nurse per patient) in hemostasis monitoring from end of procedure to patient discharge for a cost-benefit evaluation. |
Countries
Canada
Contacts
Primary ContactOlivier F Bertrand
Backup ContactMichèle Jadin
Outcome results
None listed