Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054186616
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Prospective randomised single blinded single centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/09/2006
Overall trial end date
01/09/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
800
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiology
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK) - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20488402
Publication citations
-
Results
Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL, Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention: a randomized study., JACC Cardiovasc Interv, 2010, 3, 5, 475-483, doi: 10.1016/j.jcin.2010.03.009.