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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04344314




Registration number
NCT04344314
Ethics application status
Date submitted
7/04/2020
Date registered
14/04/2020
Date last updated
22/03/2021

Titles & IDs
Public title
Impact of PIVC Length and Gauge on Catheter Indwell Time
Scientific title
A Randomized Controlled Post-market Study to Assess the Impact of Peripheral Intravenous Catheter Length and Gauge on Catheter Indwell Duration and Haemolysis in Human Participants Using a Bilateral, Cephalic Vein Cannulation Model
Secondary ID [1] 0 0
BDT-PIVCAU001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Indication for Peripheral Intravenous Catheterisation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Peripheral Intravenous Catheter

Other: Small gauge arm - 2 PIVCs of same gauge and different lengths

Other: Large gauge arm - 2 PIVCs of same gauge and different lengths


Treatment: Devices: Peripheral Intravenous Catheter
Randomised controlled

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess patent indwell time between PIVCs of different length and gauge. - Catheter indwell time for each PIVC
Timepoint [1] 0 0
72 hrs
Secondary outcome [1] 0 0
To assess haemolysis occurrence based on blood collection device, catheter device configuration - Haemolysis: Frequency of occurrence
Timepoint [1] 0 0
72 hrs

Eligibility
Key inclusion criteria
- Female or Male

- 18-65 years of age

- Not pregnant at time of recruitment within 48 hrs Day 1 procedures (self-reported)

- Normal coagulation results (prothrombin time 13-17 sec; activated partial
thromboplastin time 27-37 sec)

- Normal platelet aggregation results for ADP, TRAP, and collagen induced maximal
amplitude (>70% amplitude over 6 mins)

- Target cephalic veins readily cannulatable (i.e., = ~2.55 mm to obtain C/V ratio less
than 45% as indicated by standard 52 of the INS guidelines

- Able and willing to provide verbal and written consent

- Must be an Australian citizen with current Medicare card
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of pro coagulative state/condition (e.g. previous deep vein thrombosis

- Current hypertension (e.g., systolic >139 OR diastolic >89 mmHg)

- Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and
aspirin will be documented however not exclusionary.

- Hemophilia or any current or history of bleeding disorder or tendency

- Presence or report of current blood borne disease/infection (e.g. hepatitis, HIV,
leukemia, lymphoma)

- Difficult vascular access (i.e., vein must be readily palpable and cannulatable - no
less than ~2.55 mm diameter to maintain =45% C/V ratio) as indicated by standard 52 of
the INS guidelines

- Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin
adhesives

- BMI <18.5 kg/m2 or =35 kg/m2

- Positive results for the urine drug screen at screening or check-in (including
opiates, methadone, cocaine, amphetamines)

- History or presence of alcoholism (self-reported) or drug abuse within the past 2
years

- A current or previous medical, physical, mental/cognitive disorders or anatomical
conditions that, in the opinion of the investigator, would place the patient at risk,
would make them unable to perform study procedures or has the potential to confound
interpretation of the study results. (e.g., musculo-skeletal injury, chronic back
pain)

- Employed by Becton Dickinson, Teleflex Medical, Smiths Medical or B Braun (conflict of
interest)

Study design
Purpose of the study
Basic Science
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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] 0 0
Griffith University - Gold Coast
Recruitment postcode(s) [1] 0 0
4111 - Gold Coast

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Becton, Dickinson and Company
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Griffith University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a single-centre, open-label, multi-visit study design, in 40 healthy participants,
randomized by gauge of peripheral intravenous catheter (PIVC) device into the lower arm
cephalic vein of both arms.

The purpose of this study is to assess impact of catheter length and gauge on PIVC indwell
time over a 72 hour period. This study will also evaluate the incidence of haemolysis using
blood draws from the PIVC.
Trial website
https://clinicaltrials.gov/show/NCT04344314
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications