Hemostasis, Injury of Radial Artery, Peripheral Artery Occlusion
Conditions
Keywords
Coronary angiography, Transradial, Patient experience, VAS, Compression device
Brief summary
The transradial route is used in 90% of the coronary angiograms performed at Oslo University Hospital (OUS), Ullevål. A compression device needs to be applied after the procedure to achieve hemostasis. Patients and staff will benefit from using a device that yields safe and painless hemostasis. Patients will be randomly assigned to receive either the standard compression device (control group, A) or a recently developed compression device (experimental group, B). The study will be designed as a non-inferiority, prospective randomized controlled trial, with outcome measures being patient comfort during compression time and complication rates. Complications that will be measured are radial artery occlusion (RAO) measured using ultrasound at a follow up visit. Hematomas or bleeds from the puncture site after application of the compression device will also be classified as complications. The aim of the study is to investigate whether the new device, RY-STOP is non-inferior compared to the standard device, when considering the outcome measures.
Interventions
DEVICERY-STOP hemostasis device
DEVICETR-Band, Terumo
Sponsors
Helse Sor-Ost
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing coronary angiograms via the transradial route
Exclusion criteria
* Patients who have a long way to travel for the follow up, ultrasound scan * Patients that do not understand Norwegian * Patients presenting with acute ST segment elevation myocardial infarction (STEMI)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery occlusion | 90-120 days | Subjects wil have an ultrasound scan of their radial artery preformed after their transradial coronary angiogram to see the rate of occluded arteries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient experience | 1-4 hours | Patients will be asked to rate their comfort level associated with the hemostasis device they have been assigned |
| Device complications | 1-4 hours | Staff responsible for the application of the hemostasis devices will be asked to observe and record bleeds and hematomas that occur. |
Countries
Norway
Outcome results
None listed