Clinical trial NCT03298126: Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
Official title: Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Artery Occlusion
Keywords: Radial artery occlusion
TR band
Transradial catheterization
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The parallel group, non-inferiority trial
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Radial artery occlusion (RAO)
timeFrame: from TR band removal upto 24 hours of hospital stay of the patient
Secondary outcomes:
measure: Hematoma
timeFrame: from TR band removal upto 24 hours of hospital stay of the patient
measure: Re bleed
timeFrame: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Nasir M Rahman, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahman N, Artani A, Baloch F, Artani M, Fatima H, Salam A, Ahmed S. Role of trans-radial band protocols in radial artery occlusion: Randomized trial. Asian Cardiovasc Thorac Ann. 2021 Jun 29:2184923211027790. doi: 10.1177/02184923211027790. Online ahead of print.