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Trial registered on ANZCTR
Registration number
ACTRN12612000930886
Ethics application status
Not yet submitted
Date submitted
24/08/2012
Date registered
31/08/2012
Date last updated
1/12/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
Complications associated with two power-injectable Peripherally Inserted Central Catheters (PICCs).
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Scientific title
Adverse events and costs associated with two power-injectable Peripherally Inserted Central Catheters (PICCs) at an adult hospital: A randomised controlled trial.
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Secondary ID [1]
280954
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nil
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Universal Trial Number (UTN)
U1111-1133-2075
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Catheter related blood stream infection
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Deep vein thrombosis
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Occlusion
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Catheter fracture and dislodgement
287059
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Ongoing pain and bleeding
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Infiltration/extravasation
287061
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Phlebitis
287062
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Condition category
Condition code
Blood
287384
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0
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Clotting disorders
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Infection
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Adult patients who are already assigned to receive a PICC as part of their standard medical care will be randomly allocated to receive either an anti-thrombotic or a third-generation polyurethane proximal valve, power-injectable PICC. Both PICCs will be inserted using the same method (modified-Seldinger technique) by specially trained registered nurses in the Radiology department. The duration of the procedure varies according to the vasculature of the patient but approximately takes 30 minutes. Both PICCs have power-injectable capability and incorporate proximal valves, they differ in regards to the materials they are manufactured from; one is a third generation polyurethane and the other contains an anti-thrombotic polymer. The PICC will stay in situ until treatment is completed or as decided by the treating team.
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Intervention code [1]
285436
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Treatment: Devices
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Comparator / control treatment
Patients who receive proximal valve third-generation polyurethane power-injectable PICCs (current practice).
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Control group
Active
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Outcomes
Primary outcome [1]
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A composite measure of adverse events, namely if a patient has one or more of the following: catheter related blood stream infection (CR-BSI), local infection, deep vein thrombosis (DVT), occlusion, bleeding, ongoing pain, infiltration/extravasation, phlebitis, or catheter fracture and dislodgement will be recorded. Premature removal will also be documented. These will be defined as the number of adverse events and removal per 1000 PICC days. These outcomes will be assessed using hospital reports, medical records and patient interviews.
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Assessment method [1]
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Timepoint [1]
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The number of adverse events and need for removal will be measured at 58 days post-insertion. This time period will be measured as the period of risk regardless of whether patients still have a PICC in situ due to longer treatment regimens.
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Secondary outcome [1]
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A cost-benefit analysis will indicate the total cost associated with use of anti-thrombotic PICCs to the hospital and analyse whether there is an overall cost saving or loss compared to third generation polyurethane PICCs. An overall cost for the hospital will be determined for each PICC which will include insertion and adverse event management costs.
Insertion costs will be determined from hospital data. Adverse event management costs will be obtained from Australian Health Department data (AR-DRG codes) as well as wage/equipment costs.
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Assessment method [1]
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Timepoint [1]
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The cost-benefit analysis will be undertaken after adverse event data collection is completed.
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Eligibility
Key inclusion criteria
- All adult (18 years or older) patients who are to have a PICC inserted above the ante-cubital fossa region (as per normal practice) by one of the two lead nurse PICC inserters in the Radiology Department at the proposed study site.
- Agree to and are able to be followed up by telephone
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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
- Inability to provide informed consent due to neurological barriers (diagnosis of dementia; uncontrolled mental illness or cognitive deficits)
- Unable to read, write or understand English
- Have already been included in the trial
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Study design
Purpose of the study
Treatment
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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)
Once the patient has consented and is allocated to a diagnostic group by the researcher, the participant will enter into a procedure room where the PICC inserter will choose the next sequential envelope in the series relevant to the treatment group. A sealed, opaque envelope system will be used to indicate which PICC type to use.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software will be performed by an independent statistician. A stratified randomisation method will be used based on diagnosis types; ‘haematological cancers’, ‘solid tumours’, ‘infection’ and ‘other’ due to differences in risk.
These results will then be placed in opaque envelopes as mentioned above.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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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
Withdrawn
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Reason for early stopping/withdrawal
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Date of first participant enrolment
Anticipated
14/01/2013
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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
304
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Individual
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Name
Ms. Rebecca Sharp
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Address
PhD student
c/o - School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
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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]
284691
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Royal Adelaide Hospital Ethics Committee
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Ethics committee address [1]
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Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
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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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09/01/2013
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Approval date [1]
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Ethics approval number [1]
287780
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Ethics committee name [2]
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University of South Australia Human Research Ethics Committee
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Ethics committee address [2]
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University of South Australia
GPO Box 2471
Adelaide SA 5001
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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01/11/2012
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Approval date [2]
287781
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Ethics approval number [2]
287781
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Summary
Brief summary
The proposed study will evaluate the safety and costs associated with use of two PICC designs. The primary aim is to ascertain whether a new anti-thrombotic design is associated with less adverse events and need for removal than third-generation polyurethane. Additionally costs associated with using this new technology will be evaluated.
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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 Rebecca Sharp
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Address
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Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
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Country
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Australia
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Phone
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+61 8 830 22663
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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 Ms. Rebecca Sharp
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Address
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School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
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Country
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Australia
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Phone
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+61 8 830 21378
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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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Prof Professor Adrian Esterman
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Address
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Professor of Biostatistics
Division of Health Sciences,
University of South Australia
North Terrace Adelaide,
South Australia, 5001
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Country
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Australia
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Phone
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+61 8 830 22163
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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