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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).
Scientific title
Adverse events and costs associated with two power-injectable Peripherally Inserted Central Catheters (PICCs) at an adult hospital: A randomised controlled trial.
Secondary ID [1] 280954 0
nil
Universal Trial Number (UTN)
U1111-1133-2075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter related blood stream infection 287056 0
Deep vein thrombosis 287057 0
Occlusion 287058 0
Catheter fracture and dislodgement 287059 0
Ongoing pain and bleeding 287060 0
Infiltration/extravasation 287061 0
Phlebitis 287062 0
Condition category
Condition code
Blood 287384 287384 0 0
Clotting disorders
Infection 287385 287385 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285436 0
Treatment: Devices
Comparator / control treatment
Patients who receive proximal valve third-generation polyurethane power-injectable PICCs (current practice).
Control group
Active

Outcomes
Primary outcome [1] 287706 0
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.
Timepoint [1] 287706 0
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.
Secondary outcome [1] 298661 0
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.
Timepoint [1] 298661 0
The cost-benefit analysis will be undertaken after adverse event data collection is completed.

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

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
14/01/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
304
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285835 0
Self funded/Unfunded
Name [1] 285835 0
Country [1] 285835 0
Primary sponsor type
Individual
Name
Ms. Rebecca Sharp
Address
PhD student
c/o - School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 284691 0
None
Name [1] 284691 0
Address [1] 284691 0
Country [1] 284691 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287780 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 287780 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 287780 0
Australia
Date submitted for ethics approval [1] 287780 0
09/01/2013
Approval date [1] 287780 0
Ethics approval number [1] 287780 0
Ethics committee name [2] 287781 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 287781 0
University of South Australia
GPO Box 2471
Adelaide SA 5001
Ethics committee country [2] 287781 0
Australia
Date submitted for ethics approval [2] 287781 0
01/11/2012
Approval date [2] 287781 0
Ethics approval number [2] 287781 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34522 0
Dr Rebecca Sharp
Address 34522 0
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 34522 0
Australia
Phone 34522 0
+61 8 830 22663
Fax 34522 0
Email 34522 0
[email protected]
Contact person for public queries
Name 17769 0
Ms. Rebecca Sharp
Address 17769 0
School of Nursing and Midwifery
Division of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 17769 0
Australia
Phone 17769 0
+61 8 830 21378
Fax 17769 0
Email 17769 0
[email protected]
Contact person for scientific queries
Name 8697 0
Professor Adrian Esterman
Address 8697 0
Professor of Biostatistics
Division of Health Sciences,
University of South Australia
North Terrace Adelaide,
South Australia, 5001
Country 8697 0
Australia
Phone 8697 0
+61 8 830 22163
Fax 8697 0
Email 8697 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.