Transradial AngiogramNCT01326455
Caring for the Radial Artery Post-angiogram
A study testing Terumo TR wristband and Clo-Sur-P.A.D. in people with Transradial Angiogram, run by University of Alberta.
Trial summary
The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transradial Angiogram
- What is being tested?
- Terumo TR wristband and Clo-Sur-P.A.D.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nonemergent
- outpatient
Who cannot join
- inpatients
- emergency patients
- booked angioplasty patients
- cognitive impairment
- those in whom the approach was initiated but aborted due to inability to puncture the radial artery
About this study
Official title: Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression
The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. However, in the last 20 years, the radial artery has gained more popularity among physicians and patients, thereby offering an alternative to the femoral approach. Various methods of applying compression to the radial puncture site have been used, but no research has been done to show what best practice is. In this case, best practice would be the most effective way of getting hemostasis while limiting complications and ensuring the efficient use of nursing and medical resources. It is hypothesized that statistically significant differences are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as compared with the control Terumo group, without increasing vascular complications.
- Conditions
- Transradial Angiogram
- Being tested
- Terumo TR wristband, Clo-Sur-P.A.D.
- Keywords
- transradial, angiogram, device, Care of the radial artery post transradial angiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Terumo TR wristbandDevice
A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air.
First deflation of 3cc of air occurred 1 hour after inflation. Deflations occurred every 15 minutes unless bleeding was noted. If bleeding was noted, balloon was reinflated (1-3cc of air) until bleeding stopped. Next deflation occurred 30 minutes later, at which point regular 15 minutes deflations occurred if no bleeding noted. Band was removed 1 hour after final deflation.
Terumo TR wristbandDevice
A transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air.
First balloon deflation of 3cc of air occurred 15 minutes after initial inflation. Deflations occurred every 15 minutes unless bleeding was noted. If active bleeding was noted, the balloon was re-inflated (1-3cc) until bleeding stopped. The next deflation occurred 15 minutes later. If no bleeding occurred, deflations continued every 15 minutes until the balloon was completely deflated. The band was removed 15 minutes after final deflation.
Clo-Sur-P.A.D.Device
A hydrophilic dressing has a high affinity for water, and absorbs and controls body fluid. The positively charged 4x4 centimetre pad reacts with the neuraminic acid residue on red blood cells causing agglutination of the cells. The Clo-Sur P.A.D. works outside of the clotting cascade.
The radial catheter was removed and occlusive pressure applied on the radial artery. Pressure was released just until bleeding noted \& the pad was applied with approximately 5 minutes of manual compression. The pad was assessed every 15 minutes for 90 minutes to ensure hemostasis. The pad was removed on post-CATH day 1.
| Study group | Role | What they receive |
|---|---|---|
| Terumo Control | Other | Not described Receives: Device: Terumo TR wristband |
| Terumo Fast Release | Active comparator | Not described Receives: Device: Terumo TR wristband |
| Clo-Sur P.A.D. | Active comparator | Not described Receives: Device: Clo-Sur-P.A.D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Requiring Intervention After Initial Hemostasis Achieved
Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Measured: Assessed after initial hemostasis achieved
Bleeding Requiring Intervention Post-CATH Day 1
Number of Participants with Bleeding Requiring Intervention post-CATH Day 1
Measured: Assessed post-CATH Day 1
Secondary outcomes (5)
Time to Discharge
Time to discharge in minutes.
Measured: Assessed on day of angiogram.
Hematoma or Bruising at Discharge
Number of Participants with hematoma or bruising at discharge
Measured: Assessed at discharge
Hematoma or Bruising Post-CATH Day 1
Number of Participants with hematoma or bruising post-CATH Day 1
Measured: Assessed post-CATH day 1.
Radial Artery Occlusion Post-CATH
Number of Participants with Radial Artery Occlusion post-CATH
Measured: Assessed via plethysmography and palpation post-CATH
Radial Artery Occlusion Post-CATH Day 1
Number of Participants with Radial Artery Occlusion post-CATH Day 1
Measured: Assessed via plethysmography and palpation post-CATH day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transradial AngiogramStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colleen Norris, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326455
- Sponsor's protocol ID
- Pro00005016
- Status last verified
- Sep 2011
- First submitted
- 29 Mar 2011
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fech JC, Welsh R, Hegadoren K, Norris CM. Caring for the radial artery post-angiogram: a pilot study on a comparison of three methods of compression. Eur J Cardiovasc Nurs. 2012 Mar;11(1):44-50. doi: 10.1177/1474515111429656. Epub 2012 Jan 11.
PubMed 22357780
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for the Radial Artery Post-angiogram: A Pilot Study on a Comparison of Three Methods of Compression
- ClinicalTrials.gov ID
- NCT01326455
- Acronym / sponsor ID
- Pro00005016
- Conditions
- Transradial Angiogram
- Keywords
- transradial, angiogram, device, Care of the radial artery post transradial angiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study was to compare two devices and three methods for achieving hemostasis after a transradial angiogram while assessing vascular complications and time endpoints. The heart has traditionally been accessed through the femoral artery. However, in the last 20 years, the radial artery has gained more popularity among physicians and patients, thereby offering an alternative to the femoral approach. Various methods of applying compression to the radial puncture site have been used, but no research has been done to show what best practice is. In this case, best practice would be the most effective way of getting hemostasis while limiting complications and ensuring the efficient use of nursing and medical resources. It is hypothesized that statistically significant differences are seen in time to discharge in the fast-release Terumo and Clo-Sur P.A.D. groups, as compared with the control Terumo group, without increasing vascular complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Terumo Control | Other | Device: Terumo TR wristband |
| Terumo Fast Release | Active comparator | Device: Terumo TR wristband |
| Clo-Sur P.A.D. | Active comparator | Device: Clo-Sur-P.A.D. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nonemergent
- outpatient
Key exclusion criteria (5 listed)
- inpatients
- emergency patients
- booked angioplasty patients
- cognitive impairment
- those in whom the approach was initiated but aborted due to inability to puncture the radial artery
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 |
|---|---|---|
| Terumo TR wristbandA transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First deflation of 3cc of air occurred 1 hour after inflation. Deflations occurred every 15 minutes unless bleeding was noted. If bleeding was noted, balloon was reinflated (1-3cc of air) until bleeding stopped. Next deflation occurred 30 minutes later, at which point regular 15 minutes deflations occurred if no bleeding noted. Band was removed 1 hour after final deflation. | Device | Terumo Control |
| Terumo TR wristbandA transparent unilateral compression device which is secured to the wrist via strap with velcro. The portion with the deflated 18cc balloon is placed directly over the puncture site. This balloon is inflated immediately after the catheter is removed and the balloon is inflated until bleeding visibly stops, with generally 9-18cc of air. First balloon deflation of 3cc of air occurred 15 minutes after initial inflation. Deflations occurred every 15 minutes unless bleeding was noted. If active bleeding was noted, the balloon was re-inflated (1-3cc) until bleeding stopped. The next deflation occurred 15 minutes later. If no bleeding occurred, deflations continued every 15 minutes until the balloon was completely deflated. The band was removed 15 minutes after final deflation. | Device | Terumo Fast Release |
| Clo-Sur-P.A.D.A hydrophilic dressing has a high affinity for water, and absorbs and controls body fluid. The positively charged 4x4 centimetre pad reacts with the neuraminic acid residue on red blood cells causing agglutination of the cells. The Clo-Sur P.A.D. works outside of the clotting cascade. The radial catheter was removed and occlusive pressure applied on the radial artery. Pressure was released just until bleeding noted \& the pad was applied with approximately 5 minutes of manual compression. The pad was assessed every 15 minutes for 90 minutes to ensure hemostasis. The pad was removed on post-CATH day 1. | Device | Clo-Sur P.A.D. |
Primary outcome
Bleeding Requiring Intervention After Initial Hemostasis Achieved
Time frame: Assessed after initial hemostasis achieved
Number of Participants with Bleeding Requiring Intervention after initial hemostasis achieved
Bleeding Requiring Intervention Post-CATH Day 1
Time frame: Assessed post-CATH Day 1
Number of Participants with Bleeding Requiring Intervention post-CATH Day 1
5 secondary outcomes
Time to Discharge
Time frame: Assessed on day of angiogram.
Hematoma or Bruising at Discharge
Time frame: Assessed at discharge
Hematoma or Bruising Post-CATH Day 1
Time frame: Assessed post-CATH day 1.
Radial Artery Occlusion Post-CATH
Time frame: Assessed via plethysmography and palpation post-CATH
Radial Artery Occlusion Post-CATH Day 1
Time frame: Assessed via plethysmography and palpation post-CATH day 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22357780Fech JC, Welsh R, Hegadoren K, Norris CM. Caring for the radial artery post-angiogram: a pilot study on a comparison of three methods of compression. Eur J Cardiovasc Nurs. 2012 Mar;11(1):44-50. doi: 10.1177/1474515111429656. Epub 2012 Jan 11.
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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.
Colleen Norris, PhD principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A study testing Terumo TR wristband and Clo-Sur-P.A.D. in people with Transradial Angiogram, run by University of Alberta.
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 5 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 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bleeding Requiring Intervention After Initial Hemostasis Achieved (time frame: Assessed after initial hemostasis achieved). The study lists 2 primary outcomes in all. 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 NCT01326455, 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 28 Sep 2022.