Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001354471
Ethics application status
Approved
Date submitted
Date registered
29/09/2016
Date last updated
29/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of PowerPICC(Trademark) with BioFlo(Trademark) on Peripherally-Inserted Central Catheter(PICC)-related Occlusion and Infection Rates in the Oncology/Haematology Setting: A Randomised Controlled Trial
Scientific title
Comparing the effectiveness of PowerPICC(Trademark) with BioFlo(Trademark) on PICC-related Occlusion and Infection Rates in the Oncology/Haematology Setting: A Randomised Controlled Trial
Secondary ID [1] 290193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter-related bloodstream infection 300342 0
Catheter occlusion 300343 0
Condition category
Condition code
Infection 300204 300204 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recently, BioFlo(Trademark) PICC (Angiodynamics) has become available and approved by the Therapeutic Good Administration. The technology enhancements include added Pressure Activated Safety Valve that is designed to resist back flow and reduce blood reflux on the inside of the catheter to mitigate occlusion or BSI. As well, the BioFlo(Trademark) has Endexo technology that makes the PICC more resistant to the accumulation of blood components particularly platelets and thrombus.

Patients will be randomly allocated to this intervention. The PICC lines will be inserted in Radiology by a radiologist.. A research nurse will access patients' health record weekly (coincides with weekly dressing changes) to monitor for signs of complications including blockage and bloodstream infection from the date of insertion until PICC removal. The PICC will remain in situ until device failure or no longer required, at the discretion of the treating doctor. There is no maximum duration of PICC use for the purpose of this study.
Intervention code [1] 295948 0
Treatment: Devices
Intervention code [2] 295968 0
Prevention
Comparator / control treatment
Currently, the hospital uses PowerPICC(Trademark), a powerinjectable polyurethane PICC that, is capable of an injection rate of 5 mL per second, has a kink-resistant design, and is designed to ‘better fit’ veins (smaller diameter in the middle for the peripheral veins, and larger diameter in the distal tip for the larger veins).

Patients will be randomly allocated to this intervention. The PICC lines will be inserted in Radiology by a radiologist.. A research nurse will access patients' health record weekly (coincides with weekly dressing changes) to monitor for signs of complications including blockage and bloodstream infection from the date of insertion until PICC removal. The PICC will remain in situ until device failure or no longer required, at the discretion of the treating doctor. There is no maximum duration of PICC use for the purpose of this study.
Control group
Active

Outcomes
Primary outcome [1] 299689 0
Catheter-related blood stream infection defined as a laboratory-confirmed bloodstream infection where the PICC line was in situ for 2 days or more and must be in place when the infection occurred.
Timepoint [1] 299689 0
Medical records will be checked weekly (coincides with dressing changes) to monitor for infection from time of PICC line insertion until time of central line removal.
Primary outcome [2] 299690 0
Occlusion will be judged based on the nurses’ documentation of the incidence of blockage (e.g. resistance, sluggish flow) in which interventions were employed to resolve it. Interventions include, but not limited to, flushing the line, arm repositioning, redressing, and obtaining a “PICC-o-gram” or ultrasound. Thrombosis will be determined based on the results of the “PICC-o-gram” or ultrasound.
Timepoint [2] 299690 0
Medical records will be checked weekly (coincides with dressing changes) to monitor for occlusion from time of PICC line insertion until time of central line removal.
Secondary outcome [1] 327862 0
Adverse events E.g. catheter rupture, sensitivity or allergy, severe pain
Timepoint [1] 327862 0
Medical records will be checked weekly (coincides with dressing changes) to monitor for adverse events from time of PICC line insertion until time of central line removal.

Eligibility
Key inclusion criteria
1 Adults (18 years old and over)
2 Patients referred to Queensland X-Ray Mater Private Hospital Brisbane who require a PICC line
3 Able to provide written consent or have access to a ‘person responsible’ and can provide the consent on behalf of the patient*
4 Able to speak and write English or have access to a medically-trained interpreter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Patients younger than 18 years
2 Patients who are from a non-English speaking background and do not have access to a medically-trained interpreter
3 Patients who are unable to consent and do not have access to a ‘person responsible’

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/10/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294554 0
Hospital
Name [1] 294554 0
Departmental Funding - Mater Misericordiae Limited
Country [1] 294554 0
Australia
Primary sponsor type
Hospital
Name
Departmental Funding -Mater Misericordiae Limited
Address
Nursing Research Centre; and Infrastructure and Clinical Support Group
Mater Misericordiae Limited
Raymond Terrace, South Brisbane, Queensland 4101 Australia
Country
Australia
Secondary sponsor category [1] 293424 0
None
Name [1] 293424 0
None
Address [1] 293424 0
None
Country [1] 293424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295991 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 295991 0
Mater Research HREC Office
Room 294 Level 2 Aubigny Place
Raymond Terrace South Brisbane
4101 Qld
Ethics committee country [1] 295991 0
Australia
Date submitted for ethics approval [1] 295991 0
29/06/2016
Approval date [1] 295991 0
13/09/2016
Ethics approval number [1] 295991 0
HREC/16/MHS/42

Summary
Brief summary
Peripherally inserted central catheters (PICCs) are considered a conventional mode of treatment provision in most hospitals, and mostly favoured by patients and clinicians. However, the effectiveness of PICCs can be offset by complications, most commonly occlusion and bloodstream infections. As a result, PICC technology is advancing and designed to limit complications, hence the hospital currently uses PowerPICC(Trademark). Recently, a newer product BioFlo(Trademark) claims to have better technology, thus hypothesised to have better protection against occlusion and bloodstream infections. The proposed study aims to compare and evaluate the effectiveness two types of PICC lines – BioFlo(Trademark)and PowerPICC(Trademark) - on the incidence of bloodstream infections and the incidence of occlusions in a private haematology/oncology setting. It is anticipated that the results of this study will determine the product to be used across the Mater Misericordiae Limited Brisbane.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69178 0
Dr Kathryn Kynoch
Address 69178 0
Nursing Research Centre Queensland Centre for Evidence-based Nursing and Midwifery: A Joanna Briggs Institute Centre of Excellence
Level 2 Aubigny Place
Raymond Terrace, South Brisbane
4101 Qld
Country 69178 0
Australia
Phone 69178 0
+61 7 3163 8181
Fax 69178 0
Email 69178 0
[email protected]
Contact person for public queries
Name 69179 0
Cara Cabilan
Address 69179 0
Nursing Research Centre Queensland Centre for Evidence-based Nursing and Midwifery: A Joanna Briggs Institute Centre of Excellence
Level 2 Aubigny Place
Raymond Terrace, South Brisbane
4101 Qld
Country 69179 0
Australia
Phone 69179 0
+61 7 3163 5367
Fax 69179 0
Email 69179 0
[email protected]
Contact person for scientific queries
Name 69180 0
Cara Cabilan
Address 69180 0
Nursing Research Centre Queensland Centre for Evidence-based Nursing and Midwifery: A Joanna Briggs Institute Centre of Excellence
Level 2 Aubigny Place
Raymond Terrace, South Brisbane
4101 Qld
Country 69180 0
Australia
Phone 69180 0
+61 7 3163 5367
Fax 69180 0
Email 69180 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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