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

Primary Purpose

Radial Artery Occlusion

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
TR BAND removal protocol
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Radial Artery Occlusion focused on measuring Radial artery occlusion, TR band, Transradial catheterization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aga Khan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TR BAND Protocol A

TR BAND PROTOCOL B

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Radial artery occlusion (RAO)
Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 17, 2017
Last Updated
September 26, 2017
Sponsor
Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT03298126
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Artery Occlusion
Keywords
Radial artery occlusion, TR band, Transradial catheterization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The parallel group, non-inferiority trial
Masking
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.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TR BAND Protocol A
Arm Type
Active Comparator
Arm Description
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
Arm Title
TR BAND PROTOCOL B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TR BAND removal protocol
Other Intervention Name(s)
Ultrasound doppler, plethysmography
Intervention Description
To assess radial artery patency after specific protocol used as already described in previous section.
Primary Outcome Measure Information:
Title
Radial artery occlusion (RAO)
Description
Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms
Time Frame
from TR band removal upto 24 hours of hospital stay of the patient
Secondary Outcome Measure Information:
Title
Hematoma
Description
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.
Time Frame
from TR band removal upto 24 hours of hospital stay of the patient
Title
Re bleed
Description
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.
Time Frame
from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasir M Rahman, FCPS
Organizational Affiliation
Aga Khan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aga Khan University Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34182800
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.
Results Reference
derived

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

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