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

ISRCTN ISRCTN68853500
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

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

Study information

Study designProspective randomised single blinded single centre study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesRadial 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) studiedSurgery: Thoracic
InterventionWe 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 Student’s 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measurePrimary end points: Incidence of clinical radial artery spasm.
Secondary outcome measures1. 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 date01/09/2006
Completion date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants800
Key inclusion criteriaSample 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 criteria1. 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 enrolment01/09/2006
Date of final enrolment01/09/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Cardiology
Liverpool
L14 3PE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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