Radial Artery Occlusion
Conditions
Keywords
Radial artery occlusion, TR band, Transradial catheterization
Brief summary
Coronary artery disease (CAD) is one of the major health concerns among other non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to determine the extent of disease in coronary arteries due to atherosclerosis. Among the two approaches for cardiac catheterization, trans-radial approach has gained more popularity than conventional trans-femoral approach over the past decade with availability of compression devices for radial artery that assures lesser risk of bleeding and hematoma and has translated into increased patient comfort and early mobility post procedure. Radial artery occlusion is a common complication of trans-radial procedures often ignored by the operator after procedure due to dual blood supply by ulnar artery. Although clinically silent usually, it necessitate the need of monitoring radial artery for patency because of risk of limited trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. , compression devices applied after sheath removal may be a contributing factor to radial artery occlusion because of selective pressure for extended time duration (3-4 hours). Various protocols have been developed to remove TR band by different institutions across the globe and have been tested to assess post procedure complications. To the best of what we know, there exists no standard protocol to deflate TR band. Also, the current protocol in practice at our institution has not been evaluated against other protocols that are followed in other institution across the globe claiming lesser post procedure complications. Hence, our aim was to test through a randomized trial whether our hospital standard protocol is non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser complication rate
Interventions
PROCEDURETR BAND removal protocol
To assess radial artery patency after specific protocol used as already described in previous section.
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization was carried out after written informed consent through SNOSE (Sequentially Numbered Opaque Sealed Envelopes) method to ensure allocation concealment. Patients were randomized into two groups for TR band removal i.e. Group 1 received protocol A which is currently in practice at AKUH and group 2 underwent protocol B developed by Cohen and Alfonso which is supported by literature. The techniques for protocol A and protocol B. Radial artery patency was determined at 24 hours by a trained resident doctor who was blinded to the protocol administered.
Intervention model description
The parallel group, non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted for coronary angiography in specified period of study * patients who sign informed consent
Exclusion criteria
* known radial artery occlusion * \> 3 radial angiograms in the past * plan for AD- hoc PCI * on warfarin therapy * known bleeding diathesis or hypercoagulable state * contraindication to radial artery access such as hemodialysis fistula, mastectomy or localized infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery occlusion (RAO) | from TR band removal upto 24 hours of hospital stay of the patient | Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma | from TR band removal upto 24 hours of hospital stay of the patient | Patients in both arms were assessed for the presence of hematoma in the cannulated arm used for the angiography before and after the TR band removal. Hematoma were graded from grad 1-5 according to the extent of arm involvement as per standard EASY hematoma classification system. |
| Re bleed | from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient | patients in both arms were assessed for any sign of major or minor bleeding from the punctured site, such as oozing, frank bleeding which required extra pressure to apply on the site to control it, or required extra amount of air to be inflated to control it. any such event was documented as Re bleed after the TR band application. |
Countries
Pakistan
Outcome results
None listed