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Trial registered on ANZCTR
Registration number
ACTRN12624000366550
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
28/03/2024
Date last updated
28/03/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Promoting haemostasis for central venous access devices: a randomised controlled trial
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Scientific title
Promoting haemostasis for central venous access devices: a comparison of Statseal products with standard dressing care in adult inpatients to assess impact on dressing failure.
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Secondary ID [1]
310480
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None
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Universal Trial Number (UTN)
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Trial acronym
PRESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Central venous access device - associated bleeding
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Central Venous Access Device - dressing failure
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Central Venous Access Device - infection
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Condition category
Condition code
Public Health
328023
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention arm:
StatSeal (potassium ferrate) disc or powder (Biolife, Sarasota, Florida), plus site-specific securement and dressing, see below. Application of disc vs powder will be at clinician discretion. The clinician (doctor or nurse) inserting the device will apply the StatSeal product. StatSeal will only be applied once at the application of the initial dressing. Appropriate application of the intervention will be monitored by the research nurse.
Liverpool Hospital (Site 1):
Securement (e.g. StatLock, SecurAcath or suture)
Dressing (e.g. 'Tegaderm CHG' (chlorhexidine gluconate) dressing)
Royal Brisbane and Women's Hospital (Site 2):
Securement (e.g. Statlock)
Dressing (e.g. 'Tegaderm IV Advanced' + 'Biopatch disc')
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Intervention code [1]
326868
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Prevention
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Comparator / control treatment
Control arm (no StatSeal products - standard dressing/securement only):
Liverpool Hospital (Site 1):
Securement (e.g. StatLock, SecurAcath or suture)
Dressing (e.g. 'Tegaderm CHG' (chlorhexidine gluconate) dressing)
Royal Brisbane and Women's Hospital (Site 2):
Securement (e.g. Statlock)
Dressing (e.g. 'Tegaderm IV Advanced' + 'Biopatch disc')
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Control group
Active
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Outcomes
Primary outcome [1]
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The requirement for the initial central venous access device (CVAD) dressing to be replaced due to evidence of bleeding, blood staining and/or soiling or loose/lifting edges before the scheduled dressing change on day 7 post-CVAD insertion.
Requirements for the initial dressing to be changed prior to 7 days will be determined by clinical staff.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician who changed the dressing; or on review of paper or electronic medical records.
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Assessment method [1]
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Timepoint [1]
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Assessed daily from CVAD insertion up to any day prior to Day 7 post-CVAD insertion.
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Secondary outcome [1]
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Central line-associated bloodstream infection (CLABSI): as defined by the National Healthcare Safety Network (NHSN) 2023 criteria.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [1]
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Timepoint [1]
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Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
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Secondary outcome [2]
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Primary Blood Stream Infection (BSI): as defined by NHSN 2023 criteria.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [2]
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Timepoint [2]
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Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
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Secondary outcome [3]
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All-cause CVAD dressing failure: a composite measure of dressing failure resulting from a compromised CVAD dressing requiring a dressing change, for any reason, before the scheduled dressing change on day 7 post-CVAD insertion.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician who changed the dressing; or on review of paper or electronic medical records.
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Assessment method [3]
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Timepoint [3]
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Assessed daily from CVAD insertion up to any day prior to Day 7 post-CVAD insertion.
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Secondary outcome [4]
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Local infection: Localised insertion site infection (without bloodstream infection) as per NHSN 2023 criteria.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [4]
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Timepoint [4]
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Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
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Secondary outcome [5]
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Patient reported acceptability of the dressing product at application and removal.
Assessed by the Research Nurse after the initial application of the dressing and on dressing removal. Measured on a verbal scale (0 - not satisfied at all, to 10 - completely satisfied)
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Assessment method [5]
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Timepoint [5]
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After application of the allocated study dressing and on removal of the allocated study dressing.
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Secondary outcome [6]
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Serious adverse events (death, central line-associated bloodstream infection (CLABSI), central venous access device-associated skin impairment (CASI), allergic dermatitis, pressure injury stage 2 or greater)
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [6]
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Timepoint [6]
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Assessed daily from CVAD insertion until 48 hours after the study dressing is removed.
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Secondary outcome [7]
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Central venous access device (CVAD) catheter migration: defined as catheter migration of more than 2 centimetres in or out of the skin from the original insertion depth.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [7]
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Timepoint [7]
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Assessed daily from CVAD insertion until the study dressing is removed.
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Secondary outcome [8]
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Adverse events: skin outcomes including CVAD-associated skin impairment (CASI). For example, allergic dermatitis, significant contact dermatitis or pressure injury (greater or equal to stage 2) at the site.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [8]
426062
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Timepoint [8]
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Assessed daily from CVAD insertion until the study dressing is removed.
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Secondary outcome [9]
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Central venous access device (CVAD) failure: all-cause composite measure of failure resulting from pain, infiltration/extravasation, blockage/occlusion (with or without leakage), fracture, thrombosis (symptomatic or confirmed), dislodgement (complete or partial) or infection.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [9]
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Timepoint [9]
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Assessed daily from CVAD insertion until the study dressing is removed.
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Secondary outcome [10]
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Number of dressing changes per patient.
This information will be collected by the research nurse from either direct observation; discussion with the participant or clinician; or on review of paper or electronic medical records.
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Assessment method [10]
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Timepoint [10]
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During the first 7 days post-CVAD insertion.
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Secondary outcome [11]
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Cost: (products, staffing time and cost of complications). This information will be calculated based on staff estimates and expert opinion. Costs of treating complications will be based on standard local diagnosis related groups and published estimates (Tuffaha et al, 2019, Australian Health Review 43; 511-515).
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Assessment method [11]
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Timepoint [11]
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During first 7 days post-CVAD insertion.
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Secondary outcome [12]
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Staff reported acceptability of the dressing product at application and removal.
Assessed by the Research Nurse after the initial application of the dressing and on dressing removal. Measured on a verbal scale (0 - not satisfied at all, to 10 - completely satisfied)
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Assessment method [12]
432035
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Timepoint [12]
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After application of the allocated study dressing and on removal of the allocated study dressing.
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Eligibility
Key inclusion criteria
Patient is
1. 18 years or older
2. Expected to require a CVAD for 48 hours or more
3. Currently an admitted patient or expected to be admitted to the hospital within 24 hours
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient has
1. Burned or scarred skin at the CVAD insertion site
2. A known allergy to Chlorhexidine, potassium ferrate, or transparent dressing adhesives
3. Been commenced on end-of-life pathway
4. Previously enrolled in this study
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a central, web-based service (1:1) with allocation concealment until commencement of study procedures
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated in a ratio of 1:1 (control to intervention) with randomly varied permuted block sizes of between 6 and 10. Randomisation will be stratified by recruiting site.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/04/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
160
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
41583
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Wollongong
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Address [1]
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Northfields Ave, Wollongong, NSW, 2522
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Country [1]
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Australia
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Primary sponsor type
University
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Name
University of Wollongong
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Address
Northfields Ave, Wollongong, NSW, 2522
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
316652
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Metro North health Human research Ethics Committee B
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Ethics committee address [1]
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Metro North Human Research Ethics Committee B, Building 14, Rode Road, Chermside, Queensland, 4032
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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04/09/2023
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Approval date [1]
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20/10/2023
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Ethics approval number [1]
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HREC/2023/MNHB/101214
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Summary
Brief summary
When a central venous access device (CVAD – incorporates both centrally and peripherally inserted central catheters) is inserted, it breaches the body’s protective barrier – the skin. Together with the patient’s intrinsic risk factors associated with their illness (e.g., cancer and deranged metabolic function such as in critical illness), this places them at risk of persistent bleeding at the catheter exit site and systemic infections. These complications are highly correlated; bleeding at the insertion site causes dressing disruption, which is associated with an increased risk for central line-associated bloodstream infections (CLABSI).
Potassium ferrate haemostatic discs and powder (StatSeal®, Biolife, Sarasota, Florida) contain a strong haemostatic agent which has primarily been used to promote haemostasis post-interventional vascular procedures and interventional cardiology. The haemostatic disc and powder also has the option of being applied at the CVAD skin exit site, however, its role to prevent haemostasis and promote dressing integrity (thereby reducing the risk of infection with longer-dwelling venous access devices), is yet to be explored.
To provide further evidence and inform clinical practice, it is important to address this evidence-practice gap and test the safety and efficacy of the potassium ferrate products in promoting haemostasis and preventing dressing disruption for CVADs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Evan Alexandrou
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Address
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Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+61 418 453 650
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Evan Alexandrou
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Address
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Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+61 418 453 650
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Evan Alexandrou
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Address
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Room 124, Building 41 University of Wollongong, Northfields Ave, Wollongong, NSW, 2522
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Country
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Australia
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Phone
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+61 418 453 650
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified patient data underlying published results only
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
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Available to whom?
Only researchers who provide a methodologically sound proposal at the discretion of the Principal Investigator.
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Available for what types of analyses?
For IPD meta-analyses.
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How or where can data be obtained?
Data can be obtained from the Principal Investigator (Dr Evan Alexandrou;
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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