Randomised Comparison Of Introducer Sheaths And Compression Devices In Patients Undergoing Transradial Coronary Procedures

ISRCTN	ISRCTN68853500
DOI	https://doi.org/10.1186/ISRCTN68853500
Protocol serial number	N0054186616
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	The Cardiothoracic Centre Liverpool NHS Trust (UK) - NHS R&D Support Funding

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

Department of Cardiology
The Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Study information

Primary study design	Interventional
Study design	Prospective randomised single blinded single centre study
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Primary end points: Incidence of clinical radial artery spasm.
Key secondary outcome measure(s)	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.
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Department of Cardiology

Liverpool
L14 3PE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No