Cardiac CatheterisationNCT02398305
Shortening Compression Time After Radial Access for Cardiac Catheterisation
A study testing TR Band standard and TR Band Quick in people with Cardiac Catheterisation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Catheterisation
- What is being tested?
- TR Band standard and TR Band Quick
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2012to Aug 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnostic coronary angiogram
- Radial access
- 6 French sheath
Who cannot join
- Use of oral anticoagulants
- Percutaneous coronary intervention
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ
About this study
Official title: Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery
To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.
The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.
Read more
Objective of the study:
To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.
- Conditions
- Cardiac Catheterisation
- Being tested
- TR Band standard, TR Band Quick
- Keywords
- Cardiac catheterisation, Radial access, Compression, Terumo TR Band, radial artery, diagnostic
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TR Band standardDevice
Diminishing the air pressure in the TR Band following standard protocol
TR Band QuickDevice
Diminishing the air pressure in the TR Band following a faster protocol
| Study group | Role | What they receive |
|---|---|---|
| TR Band accelerated | Active comparator | Diminishing air pressure in the TR Band using accelerated protocol Receives: Device: TR Band Quick |
| TR band standard | Other | Diminishing air pressure in the TR band according to standard care Receives: Device: TR Band standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
Bleeding at puncture site after deflating pressure in TR band
Measured: 1 year
Secondary outcomes (3)
Swelling
Swelling at puncture site that is not caused by bleeding
Measured: 1 year
Patient comfort
Patient comfort, measured on VAS
Measured: 1 year
Time to discharge, after return on nursing unit
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterisationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.H.H. (Han) Deuling, University Medical Center Groningen
- Investigators
- Pim van der Harst, MD PhD, Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398305
- Sponsor's protocol ID
- METc2011-233
- Status last verified
- Mar 2015
- First submitted
- 4 Dec 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortening Compression Time of the Access Site After Cardiac Catheterisation Through the Radial Artery
- ClinicalTrials.gov ID
- NCT02398305
- Acronym / sponsor ID
- METc2011-233
- Conditions
- Cardiac Catheterisation
- Keywords
- Cardiac catheterisation, Radial access, Compression, Terumo TR Band, radial artery, diagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Mar 2015 (estimated)
- 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.
To obtain arterial access for a diagnostic cardiac catheterization or percutaneous coronary intervention (PCI) the cardiologist can choose between the femoral artery and the radial artery. In the University Medical Center Groningen the femoral artery is commonly used. After intervention the puncture site is closed with an arteriotomy closure device (ACD). Patients after radial access receive a pressure bandage at the puncture site, usually the Terumo (TR) wrist bandage.
The bedrest period for patients with an ACD is 1 hour after diagnostic cardiac catheterization and 2 hours after PCI. After the bedrest period patients are discharged 1 hour after diagnostic procedures or 4 hours after PCI. This to observe potential bleeding complications after the procedure. In patients with radial access, the TR bandage will be removed according to current protocol after 4 hours and additionally 1 hour observation is required. Several cardiologists have the intention to use the radial artery more frequent for cardiac catheterization or PCI. In a meta-analysis radial access is related to a 73% decrease in major bleeding complications compared to femoral access. Also there are no significant differences in MACE. Even so there are no differences in success percentage for cardiac catheterization or PCI and admission time is shorter for radial access (Am Heart J. 2009 Jan;157(1):132- 40). Admission time for diagnostic cardiac catheterization at the short-stay unit is in case of femoral access with an ACD approximately 2 hours. For patients after radial access post procedural admission time is approximately 5 hours. To guarantee patient throughput, uniformity of care and more efficient use of capacity of the short-stay unit, patients after radial access should not have a longer hospital admission time than patients after femoral access. Carrington et al. (J Interv Cardiol. 2009 Dec;22(6):571-5) have shown that it is safe to deflate the TR wrist band faster than four hours.
Objective of the study:
To describe the differences in safety, patient comfort and admission period after diagnostic cardiac catheterization through radial access, between the current protocol and the protocol of fast desufflation by Carrington et al.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TR Band accelerated | Active comparator | Device: TR Band QuickDiminishing air pressure in the TR Band using accelerated protocol |
| TR band standard | Other | Device: TR Band standardDiminishing air pressure in the TR band according to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic coronary angiogram
- Radial access
- 6 French sheath
Key exclusion criteria (2 listed)
- Use of oral anticoagulants
- Percutaneous coronary intervention
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 standardDiminishing the air pressure in the TR Band following standard protocol | Device | TR band standard |
| TR Band QuickDiminishing the air pressure in the TR Band following a faster protocol | Device | TR Band accelerated |
Primary outcome
Bleeding
Time frame: 1 year
Bleeding at puncture site after deflating pressure in TR band
3 secondary outcomes
Swelling
Time frame: 1 year
Patient comfort
Time frame: 1 year
Time to discharge, after return on nursing unit
Time frame: 1 year
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 25 Mar 2015.
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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.
Pim van der Harst, MD PhD study director
University Medical Center Groningen
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 standard and TR Band Quick in people with Cardiac Catheterisation, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 inclusion and 2 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 25 Mar 2015. 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 Netherlands. 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?
Bleeding (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2015.