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Trial registered on ANZCTR


Registration number
ACTRN12615001290583
Ethics application status
Approved
Date submitted
20/11/2015
Date registered
26/11/2015
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing peripherally inserted central catheter outcomes in paediatrics; a pilot randomised controlled trial
Scientific title
Randomised controlled trial in paediatrics of polyurethane PICC with endexo incorporated versus standard care polyurethane PICC to prevent PICC complication and failure
Secondary ID [1] 287949 0
Nil
Universal Trial Number (UTN)
U1111-1176-7811
Trial acronym
The PIC COMPARE trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous access device failure prior to completion of therapy 296829 0
Condition category
Condition code
Public Health 297056 297056 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in this study have peripherally inserted central catheters (PICC) in medical, surgical, anaesthetic and intensive care departments, and only paediatric patients. Consenting parents or legal guardians and patients (if appropriate) will have the type of PICC inserted randomised to either one of the following randomly assigned products

Arm 1: BioFlo polyurethane PICC with endexo technology
Arm 2 (Control): Cook polyurethane PICC

The randomly allocated PICC will be inserted using standard technique for insertion and will remain insitu until completion of therapy, or complication requiring removal. Patients will be followed until device removal, the maximum duration of follow up is 4 weeks.
Intervention code [1] 293294 0
Prevention
Intervention code [2] 293295 0
Treatment: Devices
Comparator / control treatment
Arm 2 (Control): Cook Polyurethane PICC is a PICC line with a soft polyurethane plastic for increased patient comfort whilst still offering the stability and strength of first generation polyurethane with the ability to power inject contrast at higher pressures.
Control group
Active

Outcomes
Primary outcome [1] 296659 0
PICC failure or complication: Composite measure of any reason for unplanned PICC removal or complication prior to the completion of therapy. This includes (i) central line-associated bloodstream infection (CLABSI); (ii) local infection of skin; (iii)device occlusion; (iv)venous thrombosis; (v) PICC fracture or dislodgement. The primary outcome of device failure is an objective measure, assigned by clinical staff (not research staff or investigators). This is routine clinical practice. Research staff will collect the primary endpoint from the medical records with additional information obtained from the clinical staff/patients if required.
Timepoint [1] 296659 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Primary outcome [2] 296660 0
Primary Outcome: Feasibility of a full efficacy trial as established by:
*Eligibility: Percentage of patients screened that are eligible;
*Recruitment: Percentage of eligible patients who agree to enrol;
*Retention and attrition: Percentage of participants who are lost to follow up or withdraw from study;
*Protocol adherence: Percentage of participants who rece3ive their allocated treatment throughout their study participation;
*Missing data: Percentage of data missed during study data collection;
*Parent and healthcare staff satisfaction and acceptability: Using a semi structured survey and
*Sample size estimates: a reduction in all-case CVAD failure or complication (Defined in the secondary outcomes) by at least 5% in the experimental arms, in comparison to standard care
*Biofilm formation will be identified on the internal and/or external lumens of the PICCs

Each component will be assessed by screening log, electronic data collection tool and any missed data will be obtained from electronic medical records.
Timepoint [2] 296660 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [1] 319034 0
*PICC-associated bloodstream infection (CABSI): A laboratory confirmed BSI that is not secondary to an infection at another body site (excludes Mucosal Barrier Injury LCBSI), with PICC in place for >2 calendar days on the day of the BSI (day of PICC placement being Day 1) and the PICC was in place on the date of the event or the day before, when all elements of LCBI, were first present together (see CDC NHSN for full criteria)confirmed by a blinded infectious disease specialist using de-identified clinical and microbiological data
Timepoint [1] 319034 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [2] 319035 0
*Local infection: Purulent phlebitis confirmed with a positive (greater than 15cfu) swab, but with negative or no blood culture, confirmed by blinded infectious disease specialist.
Timepoint [2] 319035 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [3] 319036 0
*Occlusion: Complete: greater than or equal to 1 lumens cannot be flushed or aspirated, or resolved post thrombolytic dwell, Partial: use of thrombolytic to resolve a withdrawal aspirate when > or equal to 1 lumen flushes but does not easily aspirate, as determined by treating clinician and data entered into electronic data collection tool
Timepoint [3] 319036 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [4] 319037 0
* Fracture: Visible split in PICC material; as examined by nursing staff and or leakage or radiographic evidence of extravasation/infiltration into tissue as determined by radiologist
Timepoint [4] 319037 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [5] 319038 0
*Venous thrombosis: suspected: too painful for the patient to tolerate, or Confirmed Ultrasound/venographic confirmed thrombosed vessel at the PICC site in a symptomatic patient, or a symptomatic patient with a thrombus/fibrin sheath occluding 1 or more lumen at PICC removal. The PICC material will be examined by nursing staff on device removal.
Timepoint [5] 319038 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [6] 319039 0
*Safety endpoints: Any local or systemic allergic reactions e.g. pruritis as assessed by research nurse and recorded in electronic data collection tool.
Timepoint [6] 319039 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [7] 319040 0
*PICC dwell time: hours from insertion until removal. This data will be collected on electronic data collection tool.
Timepoint [7] 319040 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [8] 319041 0
*Patient or parent (when the patient is unable to answer) acceptability: using11 point numeric rating scales
Timepoint [8] 319041 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [9] 319042 0
*Healthcare costs: Composite measure of estimates of direct product costs, healthcare resource utilisation (including additional equipment, staff time) and failure-associated resource usage using previously established cost estimates
Timepoint [9] 319042 0
At study completion
Secondary outcome [10] 319102 0
Staff satisfaction and acceptability ranked on a 11point scale
Timepoint [10] 319102 0
At removal of device, on complication or at 4 weeks whichever time point occurs first
Secondary outcome [11] 324798 0
Phlebitis - Any sign of chemical, mechanical or infective phlebitis as determined by patient complaint of pain and nurse examining PICC site
Timepoint [11] 324798 0
At removal of device, on complication or at 4 weeks whichever time point occurs first

Eligibility
Key inclusion criteria
*Require PICC insertion for fluid or medication administration;
*likely to remain an inpatient for greater than or equal to 24 hours;
*able to provide informed consent
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*non-tunnelled, tunnelled, dialysis or implanted CVADs or pulmonary artery catheters;
*Current bloodstream infection
*PICC to be inserted through diseased, burned or scarred skin';
Allergy to study product; and
Previous study enrolment in this admission to hospital

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)
The research nurse (RN) will screen patients daily (screening Log kept). The study RN will gain informed consent and perform randomisation. The RN will have the study products in pre-packs and liaise closely with the ordering and inserting surgeon. All eligible patients (or their representative) will be approached for written informed consent by the RN or inserter. If this is given, the staff member uses a centralised web-based randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation will be in a 1:1 ratio between the two study groups. Permuted blocks in randomly varied sizes will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Efficacy
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4697 0
Lady Cilento Children's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 292429 0
Commercial sector/Industry
Name [1] 292429 0
Angiodynamics
Address [1] 292429 0
10 Glen Falls Tech Park,
Glen Falls,
New York
12801
Country [1] 292429 0
United States of America
Primary sponsor type
University
Name
Griffith University
Address
Nathan Campus,
170 Kessels Road,
Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 291121 0
None
Name [1] 291121 0
Address [1] 291121 0
Country [1] 291121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293891 0
Lady Cilento Children's Hospital
Ethics committee address [1] 293891 0
Level 7,
Centre for Children's Health Research,
62 Graham Street,
South Brisbane,
QLD 4101
Ethics committee country [1] 293891 0
Australia
Date submitted for ethics approval [1] 293891 0
26/10/2015
Approval date [1] 293891 0
20/11/2015
Ethics approval number [1] 293891 0
HREC 15 QRCH 164

Summary
Brief summary
Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling.
While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment.

Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now being used intermittently, on the basis of some clinician preference, at the LCCH, the PAH and elsewhere. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken.

At LCCH we plan to undertake a randomized controlled trial. Children or parents and guardians who consent to participate in the trial will be randomly assigned to either study group. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment,
retention and protocol fidelity. The secondary aim is to compare the effectiveness of this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61702 0
Ms Tricia Kleidon
Address 61702 0
Lady Cilento Children's Hospital
Level 7
501 Stanley Street
South Brisbane Qld 4101
Country 61702 0
Australia
Phone 61702 0
+61 (0)407175301
Fax 61702 0
Email 61702 0
tricia.kleidon@health.qld.gov.au
Contact person for public queries
Name 61703 0
Ms Tricia Kleidon
Address 61703 0
Lady Cilento Children's Hospital
Level 7
501 Stanley Street
South Brisbane Qld 4101
Country 61703 0
Australia
Phone 61703 0
+61 (0)407175301
Fax 61703 0
Email 61703 0
tricia.kleidon@health.qld.gov.au
Contact person for scientific queries
Name 61704 0
Ms Tricia Kleidon
Address 61704 0
Lady Cilento Children's Hospital
Level 7
501 Stanley Street
South Brisbane Qld 4101
Country 61704 0
Australia
Phone 61704 0
+61 (0)407175301
Fax 61704 0
Email 61704 0
tricia.kleidon@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary