Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion

Radial Artery Occlusion Clinical Trial

Official title:

Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298126
• Other study ID #: 4402-MED-ERC-16
• Status: Completed
• Phase: N/A
• First received: September 17, 2017
• Last updated: September 26, 2017
• Start date: February 1, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Radial Artery Occlusion

Intervention

Procedure:
• TR BAND removal protocol
To assess radial artery patency after specific protocol used as already described in previous section.

Locations

Country	Name	City	State
Pakistan	Aga Khan University Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion (RAO)	Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms	from TR band removal upto 24 hours of hospital stay of the patient
Secondary	Hematoma	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.	from TR band removal upto 24 hours of hospital stay of the patient
Secondary	Re bleed	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.	from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient