Radial Artery OcclusionNCT03298126
Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
A study testing TR BAND removal protocol in people with Radial Artery Occlusion, run by Aga Khan University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- TR BAND removal protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2017to 30 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for coronary angiography in specified period of study
- patients who sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- TR BAND removal protocol
- Keywords
- Radial artery occlusion, TR band, Transradial catheterization
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR BAND removal protocolProcedure or surgery
Also called Ultrasound doppler, plethysmography
To assess radial artery patency after specific protocol used as already described in previous section.
| Study group | Role | What they receive |
|---|---|---|
| TR BAND Protocol A | Active comparator | 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 Receives: Procedure: TR BAND removal protocol |
| TR BAND PROTOCOL B | Active comparator | 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. Receives: Procedure: TR BAND removal protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial artery occlusion (RAO)
Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms
Measured: from TR band removal upto 24 hours of hospital stay of the patient
Secondary outcomes (2)
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.
Measured: from TR band removal upto 24 hours of hospital stay of the patient
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.
Measured: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Feb 2017
- Primary completion30 Jul 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The parallel group, non-inferiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasir Rahman, Aga Khan University
- Investigators
- Nasir M Rahman, FCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298126
- Sponsor's protocol ID
- 4402-MED-ERC-16
- Status last verified
- Sep 2017
- First submitted
- 17 Sep 2017
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34182800
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion
- ClinicalTrials.gov ID
- NCT03298126
- Acronym / sponsor ID
- 4402-MED-ERC-16
- Conditions
- Radial Artery Occlusion
- Keywords
- Radial artery occlusion, TR band, Transradial catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The parallel group, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| TR BAND Protocol A | Active comparator | Procedure: TR BAND removal protocolIn 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 |
| TR BAND PROTOCOL B | Active comparator | Procedure: TR BAND removal protocolIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted for coronary angiography in specified period of study
- patients who sign informed consent
Key exclusion criteria (6 listed)
- known radial artery occlusion
- > 3 radial angiograms in the past
- plan for AD- hoc PCI
- on warfarin therapy
- known bleeding diathesis or hypercoagulable state
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TR BAND removal protocolAlso: Ultrasound doppler, plethysmographyTo assess radial artery patency after specific protocol used as already described in previous section. | Procedure or surgery | TR BAND PROTOCOL B, TR BAND Protocol A |
Primary outcome
Radial artery occlusion (RAO)
Time frame: from TR band removal upto 24 hours of hospital stay of the patient
Radial artery patency was assessed in both groups by ultrasound doppler and bed side plethysmographic waveforms
2 secondary outcomes
Hematoma
Time frame: from TR band removal upto 24 hours of hospital stay of the patient
Re bleed
Time frame: from the time of TR band application, during its removal and upto 24 hours of hospital stay of the patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Derived from this study: PubMed 34182800Rahman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasir M Rahman, FCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TR BAND removal protocol in people with Radial Artery Occlusion, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radial artery occlusion (RAO) (time frame: from TR band removal upto 24 hours of hospital stay of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03298126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.