Randomised Comparison Of Introducer Sheaths And Compression Devices In Patients Undergoing Transradial Coronary Procedures
ISRCTN | ISRCTN68853500 |
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DOI | https://doi.org/10.1186/ISRCTN68853500 |
Secondary identifying numbers | N0054186616 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 12/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Rathore
Scientific
Scientific
Department of Cardiology
The Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom
Study information
Study design | Prospective randomised single blinded single centre study |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | Radial artery spasm is a common complication and several small studies have shown conflicting results with the use of different spasmolytic cocktails prior to transradial access. Several different length sheaths are used by radial operators and there are no studies done so far to compare different sheaths and their effects on access site outcomes and impact on radial artery physiology. Some radial operators routinely use different spasmolytic cocktail prior to transradial procedures with no studies so far convincingly supporting this action. Several different post procedure haemostatic techniques have been used ranging from tourniquets, compression devices and hydrophilic wound dressings. Various haemostatic compression devices specific to radial artery are marketed and Radistop [RADI Medical Systems B] and TR Band [Terumo] are widely used. There are no comparative studies done between these compression devices on outcomes and patient tolerance. Recently there have been reports of sterile inflammatory abscesses with the usage of sheaths with hydrophilic coatings. These inflammatory reactions are reported in 2-3% of cases [39-41]. The ramifications of radial artery occlusion and injury are important not only in patients undergoing repeat interventional procedures, but also in patients in whom the radial artery may be used as a conduit for coronary artery bypass surgery or in patients needing arterio venous fistula for haemodialysis. Radial artery spasm is a common morbidity which can cause considerable discomfort to the patient and can prevent successful completion of procedure. To assess the impact of length and hydrophilic coating of the transradial introducer sheath on incidence of radial artery occlusion, radial artery spasm, local inflammatory reaction and other vascular complications. To compare the impact of the TR band and Radistop compression haemostatic devices on the time taken to achieve haemostasis, radial artery occlusion rates, local vascular complications and patients tolerance of the device. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Surgery: Thoracic |
Intervention | We will invite and screen all patients considered for coronary catheterisation and coronary intervention by the transradial approach. Patients will be allocated in random fashion to different treatment strategies. Method of randomisation: simple randomisation by opening an envelope just before procedure in catheterisation laboratory. Continuous variables will be described as mean +/- SD and compared using Students t test. Categorical variables will be expressed as frequencies and compared by chi-square statistics. Multivariate analysis will be performed to identify the predictors of radial artery spasm and radial artery occlusion. This will be a prospective, randomised, single blinded, single centre study. Patients will be randomised in factorial design as follows: 1:1:1:1 Randomisation to following sheaths: - Long [23 cm] hydrophilic coated sheath - Long [23 cm] uncoated sheath - Short [13 cm] hydrophilic coated sheath - Short [13 cm] uncoated sheath 1:1 Randomisation to following compression devices to achieve haemostasis at the end of procedure - TR band vs Radistop compression device |
Intervention type | Device |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | |
Primary outcome measure | Primary end points: Incidence of clinical radial artery spasm. |
Secondary outcome measures | 1. Incidence of radial artery occlusion rates 2. Incidence of local vascular complications 3. Incidence of sterile inflammatory reaction 4. Incidence of spontaneous recanalisation of radial artery 5. Time to achieve haemostasis 6. Patient tolerance of haemostatic deviceThis study will help us in defining the problem of radial artery spasm, radial artery occlusion and local vascular complications. This study results will help us in deciding the best sheath and compression device from the variety of products available commercially for transradial coronary procedures. |
Overall study start date | 01/09/2006 |
Completion date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Not Specified |
Target number of participants | 800 |
Key inclusion criteria | Sample size - Clinical radial artery spasm rates are reported between 20-30% [as per literature] and to detect 50% reduction in incidence of radial artery spasm, we need to recruit 175 [200] patients in each arm. This is with significance level of 0.05 [alpha error], and power of 80% [beta error- .02]. In total we need 800 patients with 200 patients in each arm of different sheath type. There will therefore be 400 patients in each arm of compression device randomisation [TR band vs. Radistop]. Target population - All patients considered for coronary angiography and coronary intervention by the transradial approach. Inclusion Criteria: 1. Intended transradial coronary procedure 2. Patient > 18 years of age and able to give informed consent. All patients undergoing transradial procedure at the Cardiothoracic Centre, Liverpool under the care of JLM, RHS, RAP, NDP [after taking their permission] will be contacted about the study and procedures will be explained. Willing patients will then be assessed in detail and informed consent will be obtained. |
Key exclusion criteria | 1. Unable or unwilling to give informed consent 2. Inability to demonstrate the presence of ulnar collateral circulation 3. Patients with A-V fistula or patients with chronic renal failure 4. Previous ipsilateral transradial procedure |
Date of first enrolment | 01/09/2006 |
Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Cardiology
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
The Cardiothoracic Centre Liverpool NHS Trust (UK) - NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/05/2010 | Yes | No |