None listed
Conditions
Brief summary
Advances continue to be made in the diagnosis and treatment of coronary heart disease. As well as innovations in opening up blocked arteries, ways of accessing the heart arteries have improved leading to reduced complications following a procedure. One such approach uses the radial artery, an artery in the wrist. Various methods exist to stop the bleeding following a procedure with the most common device being a TR BandTM (Terumo) which is applied to the wrist. A balloon in the device, when inflated with air, applies pressure to the puncture causing it to close. The manufacturers of the device recommended an inflation time of 120 minutes. Yet, no research was conducted to determine if that time was effective. Anecdotally, there are variations on the inflation time with little evidence to support those choices. The ORBIT trial will compare the manufacturer's inflation time (120 mins) [Control} with a 60 minute inflation time.[Experiment]. Two cohorts of patients will be recruited: people only having a diagnostic procedure, and people who are having a procedure to open up a blocked heart artery. IT is hypothesized that there will be no difference in bleeding [Primary Endpoint} between the control (120 mins) and experimental (60 min) groups.
Interventions
The Experimental Group will have the TR-BandTM (Terumo) inflated for 60 minutes prior to commencement of deflation versus the Control Group which will have 120 minute inflation time prior to commencement of deflation. The inflation of the device occurs immediately post-procedure both groups. The Interventional Cardiologist or Fellow undertaking the procedure will apply and inflate the device immediately following the procedure. A nurse, with a minimum of 2 years experience in managing TR-BandTM
The Experimental Group will have the TR-BandTM (Terumo) inflated for 60 minutes prior to commencement of deflation versus the Control Group which will have 120 minute inflation time prior to commencement of deflation. The inflation of the device occurs immediately post-procedure both groups. The Interventional Cardiologist or Fellow undertaking the procedure will apply and inflate the device immediately following the procedure. A nurse, with a minimum of 2 years experience in managing TR-BandTM (Terumo) devices shall undertake the observation, management and deflation of the device. A protocol for each arm has been developed for the trial. A Clinical Report Form (CRF) will be used by the nurse to collect the data throughout the deflation period including any occurrence of the primary outcome (Bleeding). A sticker for the patient's notes will indicate which arm the patient has been allocated to. The CRF will also have the allocated group printed clearly on the form. The participant will receive a Participant Information and Consent Form (PICF) to complete prior to receiving any sedative agents. The PICF will outline the procedure and what is expected of the participant.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any patient undergoing diagnostic coronary angiography or percutaneous coronary intervention; 2. Use of a 6F radial artery sheath for access; and 3. Intra-procedural administration of 5000 units of heparin.
Exclusion criteria
1. Concomitant use of other arterial access sites; 2. Patient has received thrombolytic therapy up to 12 hours prior to sheath removal; 3. Patient has received Gp IIb/IIIa antagonists up to 24 hours prior to sheath removal; 4. Estimated glomerular filtration rate (eGFR, based on the Modification of Diet in Renal Disease criteria) less than 30 mL/min per 1.73 m2; 5. Patient has received subcutaneous enoxaparin up to 12 hours prior to sheath removal when eGFR is known to be greater than 35mL/min/1.73 m2; 6. Patient has received subcutaneous enoxaparin up to 24 hours prior to sheath removal when eGFR is known to be equal to 35mL/min/1.73 m2; 7. Patient has received heparin up to 6 hours prior to sheath removal 8. Platelet count less than 100 x1^9/L; 9. Prothrombin ratio (PR) or international normalized ratio (INR) greater than 1.5 at the time of the procedure; 10. Activated partial thromboplastin time (APTT) greater than 45 seconds at the time of the procedure; and/or 11. Patient is unable to give informed consent.
Outcome results
None listed