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

NCT ID: NCT03298126

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-08-30

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

Conditions

Radial Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

TR BAND PROTOCOL B

In this group deflation was initiated after 2 hours of TR band application as described by Cohen and Alfonso. \[6\] 5 ml of air was deflated at first attempt. Next attempt was carried out after 15 minutes in which further 5 ml was removed. After 15 minutes, the remaining 2 ml of air was released from the band. In case of bleeding or hematoma at any attempt, 6 ml air was re-injected and interval for 15 minutes taken to attempt further air deflation. All the attempts and its response were recorded in the proforma filled out by the assessor.

Group Type: ACTIVE_COMPARATOR

TR BAND removal protocol

Intervention Type: PROCEDURE

To assess radial artery patency after specific protocol used as already described in previous section.

TR BAND Protocol A

In this group, air removal from TR band was initiated after 2 hours of TR band application. 3 ml of air was removed periodically at an interval of 15 minutes until all the air is eliminated from the band. In case of bleeding or hematoma while deflating air, 4 ml of air was re-injected and observed for 30 minutes until next attempt was made to deflate the band. The data including the attempts made at deflating TR band, time and amount of air injected along with the response to each deflation i.e. occurrence of bleeding or hematoma was noted down in the proforma

Group Type: ACTIVE_COMPARATOR

TR BAND removal protocol

Intervention Type: PROCEDURE

To assess radial artery patency after specific protocol used as already described in previous section.

Interventions

TR BAND removal protocol

To assess radial artery patency after specific protocol used as already described in previous section.

Intervention Type: PROCEDURE

Other Intervention Names

Ultrasound doppler, plethysmography

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Nasir Rahman

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nasir M Rahman, FCPS

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Locations

Aga Khan University Hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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. 2022 May;30(4):409 - 415. doi: 10.1177/02184923211027790. Epub 2021 Jun 29.

Reference Type: DERIVED

PMID: 34182800 (View on PubMed)

Other Identifiers

4402-MED-ERC-16

Identifier Type: -

Identifier Source: org_study_id