Radial Artery Hemostasis
Conditions
Keywords
Radial artery puncture, Radial artery occlusion, Radial artery bleeding
Brief summary
RAPHE is an open label randomized clinical trial to assess physical, biological and chemical methods of radial artery puncture hemostasis following coronary catheterization. A total of 600 subjects will be randomized in a 1:1:1 fashion to either the StatSeal, Axiostat or TR Band hemostasis devices. Follow-up of the subject will take place 60 days after the index procedure.
Interventions
DEVICERadial artery hemostasis
Each of the devices will be assessed for radial artery hemostasis.
Sponsors
Semmelweis University Heart and Vascular Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Coronary angiogram planned from a radial artery approach * Use of 5, 6 or 7 French sheaths
Exclusion criteria
* Radial artery diameter \<1.8 mm as measured via ultrasound * Established peripheral arterial disease * Known autoimmune illness * Hemodynamic instability * Pregnant or nursing * Condition following resuscitation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery bleeding | 24 hours post-procedure or at hospital discharge (whichever comes first) | Bleeding from the radial artery puncture, classified via the EASY method |
| Radial artery occlusion | 24 hours post-procedure or at hospital discharge (whichever comes first) | Frequency of radial artery occlusion after hemostasis |
| Radial artery (pseudo)aneurysm formation | 24 hours post-procedure or at hospital discharge (whichever comes first) | Frequency of radial artery (pseudo)aneurysm formation after hemostasis |
| Radial artery fistula formation | 24 hours post-procedure or at hospital discharge (whichever comes first) | Frequency of radial artery arteriovenous fistula formation after hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initial compression time of hemostatsis device | Up to 30 minutes post-procedure | Initial time (in minutes) of the hemostasis device, needed to achieve primary patent hemostasis |
| Overall compression time | Up to 24 hours post-procedure | Overall time (in minutes) of device use as a hemostatis tool |
| Number of compression devices needed | Up to 24 hours post-procedure | Overall number of compression devices needed for hemostatis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for bail-out device | Up to 24 hours post-procedure | Percentage of patients requiring bail-out hemostasis devices |
Countries
Hungary
Outcome results
None listed