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Comparison of an accelerated deflation protocol with standard practice for radial compression device following cardiac catheterisation

Comparison of an accelerated deflation protocol with standard practice for radial compression device following cardiac catheterisation in patients admitted for angiography and/or percutaneous coronary intervention with radial access

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000830594
Enrollment
200
Registered
2024-07-05
Start date
2024-08-19
Completion date
2024-10-04
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Cardiac catheterisation is an invasive cardiac procedure performed for diagnostic (angiography) and/or therapeutic (percutaneous coronary intervention [PCI]) purposes. Transradial approach to catheterisation is common, Current protocols for TR Band® deflation have been noted by staff as challenging to meet, with a recent audit identifying inconsistencies in practice and delayed deflations. Prolonged inflation times can increase the risk of radial artery occlusion (RAO). Evidence suggests that accelerated deflation protocols are safe and feasible and may reduce patient discomfort and length of stay. Various protocols have been developed and tested however, few assessed bleeding outcomes, efficiency of deflation and patient comfort. This study aims to assess the feasibility of accelerated protocols for TR Band® deflation. Outcome measures will be bleeding complications, deflation time/steps and patient comfort.

Interventions

Cardiac catheterisation is an invasive cardiac procedure performed for diagnostic (angiography) and/or therapeutic (percutaneous coronary intervention [PCI]) purposes. Transradial approach to catheterisation is common, and bleeding from the radial artery puncture site can occur when the catheter is removed. At Fiona Stanley Hospital (FSH), pressure is applied to the site post procedure for 1-2 hours to achieve haemostasis using an inflated TR Band® that is then incrementally deflated by nursing

Cardiac catheterisation is an invasive cardiac procedure performed for diagnostic (angiography) and/or therapeutic (percutaneous coronary intervention [PCI]) purposes. Transradial approach to catheterisation is common, and bleeding from the radial artery puncture site can occur when the catheter is removed. At Fiona Stanley Hospital (FSH), pressure is applied to the site post procedure for 1-2 hours to achieve haemostasis using an inflated TR Band® that is then incrementally deflated by nursing staff before removal. . The TR Band® is applied to the patient’s wrist in the cardiac catheter laboratory during removal of the catheter sheath by staff trained in this procedure. As per current policy at FSH, TR Band® deflation commences at 60 minutes after angiogram and 120 minutes after angioplasty. TR Band® deflation involves deflating the balloon by removing 3mls of air every 10 minutes until all air is removed and the TR Band® is completely deflated. Deflation is performed by nurses deemed competent in this practice and who monitor bleeding and heamatoma formation during the deflation process. Adherence to the intervention will be monitored by site investigators by direct observation.

Sponsors

Fiona Stanley Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients admitted for angiography and/or percutaneous coronary intervention with radial access

Exclusion criteria

* Inability to obtain informed consent * Procedure requiring femoral access * Peri-procedural complications including bleeding, haematoma, difficult radial artery access * Discretion of the treating interventional cardiologist if it's not in the patient's best interest

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026