Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000550404p
Ethics application status
Not yet submitted
Date submitted
23/03/2016
Date registered
28/04/2016
Date last updated
28/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to determine the Optimal TR-Band Deflation Time (ORBIT) in patients undergoing diagnostic or interventional coronary procedures
Scientific title
In patients undergoing diagnostic angiography and percutaneous coronary intervention does reducing TR Band inflation time from 120 minutes to 60 minutes have an effect on bleeding?
Secondary ID [1] 288832 0
Nil Known
Universal Trial Number (UTN)
U1111-1181-1840
Trial acronym
ORBIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease 298111 0
Bleeding 298112 0
Haemostasis 298113 0
Condition category
Condition code
Cardiovascular 298278 298278 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294287 0
Treatment: Devices
Comparator / control treatment
The TR BandTM (Terumo) will be inflated by the Interventional Cardiologist or Fellow undertaking the procedure. The device will remain inflated for 120 minutes prior to commencement of deflation. Two population groups (clusters): diagnostic angiography and percutaneous coronary intervention
Control group
Active

Outcomes
Primary outcome [1] 297764 0
Clinically significant bleed as determined by the Bleeding Academic Research Consortium (BARC) statement. The categories most likely associated with the procedures related to this study are 0 - 3c. (Mehran R, Rao SV, Bhatt DL, et al. Standardized Bleeding Definitions for Cardiovascular Clinical Trials. Circulation 2011;123:2736-47).

The details of the BARC classification are as follows:

Type Details
0 No bleeding
1 Bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional
2 Any overt, actionable sign of hemorrhage (eg. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3-5 but does meet at least one of the following criteria: 1. Requiring nonsurgical, medical intervention by a healthcare professional, 2. Leading to hospitalization or increased level of care, or 3. Prompting evaluation.
3a Overt bleeding plus hemoglobin (Hb) drop of 3 to <5 g/dL
3b Overt bleeding plus Hb drop >/= 5g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents
3c Intracranial hemorrhage (does not include microbleeds or hemorhaggic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging of lumbar puncture; intraocular bleed compromising vision
4 CABG-related bleeding
5 Fatal bleeding
Timepoint [1] 297764 0
Post-TR Band deflation
Secondary outcome [1] 322152 0
Outcome: Time to haemostasis
Assessed: The clinical nurse monitoring the patient following the procedure will record the time (HH:MM) following the final deflation where there is no sign of bleeding (BARC category 0).
Timepoint [1] 322152 0
The time from the completion of the procedure until haemostasis achieved.
Secondary outcome [2] 322633 0
Outcome: Time to ambulation
Assessed: The clinical nurse monitoring the patient following the procedure will record the time (HH:MM) following the completion of the procedure until the time the patient first ambulates.
Timepoint [2] 322633 0
The time from the completion of the procedure until the time the patient first ambulates.
Secondary outcome [3] 323225 0
The clinical nurse completing the patient's discharge process will record the time of discharge(HH:MM) and calculate the time passed between the time the procedure was completed until the time the patient was discharged from the hospital.
Timepoint [3] 323225 0
Time to discharge (HH:MM)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be blinded to the Interventional Cardiologist conducting the procedure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A series of envelopes will be prepared. An envelope is drawn at the point application of the device (TR BandTM [Terumo])
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Clustered groups:

Diagnostic Angiography:
Intervention: 60 mins
Control: 120 mins

Percutaneous Coronary Intervention
Intervention: 60 mins
Control: 120 mins
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size Considerations
Using a estimation of power for this study of 80% (1-beta), a margin of error of 5% (alpha), a non-inferiority limit of 3% (delta) and confidence level of 95% with a 1% success rate per group, A total sample size of 137 is required for each group. This gives a total population of 548. Therefore, if there is truly no difference between the standard (N1 deflation at 120 mins) and the new treatment (N2 deflation at 60 mins), Then 548 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval will exclude a difference in favour of the standard treatment of more than 3%.

Baseline Subject Characteristics
Subject demographics, baseline characteristics and medical history will be summarized descriptively by treatment groups. Mean and standard deviation will generally be reported for continuous variables; median, range and IQR may be reported instead if the data distribution is skewed. Frequencies and proportions will be reported for categorical variables.

Statistical analysis
Comparison between groups will be used using Chi squared for categorical data and the T-test for continuous variables. Tests for strength of relationships (r2) between variables will be use to measure the relationships between key factors and the study endpoints.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
548
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293194 0
Self funded/Unfunded
Name [1] 293194 0
Self Funded
Country [1] 293194 0
Primary sponsor type
University
Name
Deakin University
Address
Locked Bag 20000
Geelong Vic 3220
Country
Australia
Secondary sponsor category [1] 291993 0
Hospital
Name [1] 291993 0
Epworth HealthCare
Address [1] 291993 0
89 Bridge Road
Richmond Vic 3121
Country [1] 291993 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294680 0
Epworth Healthcare HREC
Ethics committee address [1] 294680 0
89 Bridge Road
Richmond Vic 3121
Ethics committee country [1] 294680 0
Australia
Date submitted for ethics approval [1] 294680 0
02/05/2016
Approval date [1] 294680 0
Ethics approval number [1] 294680 0
Ethics committee name [2] 294681 0
Deakin University HREC
Ethics committee address [2] 294681 0
Locked Bag 20000
Geelong Vic 3220
Ethics committee country [2] 294681 0
Australia
Date submitted for ethics approval [2] 294681 0
01/08/2016
Approval date [2] 294681 0
Ethics approval number [2] 294681 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64638 0
Dr John Xavier Rolley
Address 64638 0
School of Nursing and Midwfiery
Centre for Quality and Patient Safety Research (QPS) &
Epworth Deakin Centre for Clinical Nursing Research
Locked Bag 20000
Geelong VIC 3220
Country 64638 0
Australia
Phone 64638 0
+61352278432
Fax 64638 0
Email 64638 0
[email protected]
Contact person for public queries
Name 64639 0
A/Prof Anastasia Hutchinson
Address 64639 0
School of Nursing and Midwfiery
Centre for Quality and Patient Safety Research (QPS) &
Epworth Deakin Centre for Clinical Nursing Research
Locked Bag 20000
Geelong VIC 3220
Country 64639 0
Australia
Phone 64639 0
+61399368078
Fax 64639 0
Email 64639 0
[email protected]
Contact person for scientific queries
Name 64640 0
Dr John Xavier Rolley
Address 64640 0
School of Nursing and Midwfiery
Centre for Quality and Patient Safety Research (QPS) &
Epworth Deakin Centre for Clinical Nursing Research
Locked Bag 20000
Geelong VIC 3220
Country 64640 0
Australia
Phone 64640 0
+61352278432
Fax 64640 0
Email 64640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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