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| [ ...Back to search results ] | [ Print-friendly version ] |
| Randomised Comparison Of Introducer Sheaths And Compression Devices In Patients Undergoing Transradial Coronary Procedures |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN68853500 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0054186616 |
| Public title | Randomised Comparison Of Introducer Sheaths And Compression Devices In Patients Undergoing Transradial Coronary Procedures |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Surgery: Thoracic |
| 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. |
| Design/methodology | Prospective, randomised, single blinded, single centre study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 yrs of age and able to give informed consent. All patients undergoing transradial procedure at our centre [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. 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. |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 01/09/2007 |
| Status of trial | Completed |
| Target number of participants | 800 |
| Interventions | We will invite and screen all patients considered for coronary catheterisation and coronary intervention by the transradial approach. 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. |
| Primary outcome measure(s) | Primary end points: Incidence of clinical radial artery spasm. |
| 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 device. This 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. |
| Sources of funding | The Cardiothoracic Centre Liverpool NHS Trust NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall London United Kingdom SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr S Rathor |
| Contact details | Dept. of Cardiology The Cardiothoracic Centre Thomas Drive Liverpool United Kingdom L14 3PE |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN68853500 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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