Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)

NCT ID: NCT06806709

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2026-08-31

Brief Summary

Blood cultures (BCs) are a blood test to look for an infection. Two problems with the sample collection are contamination by germs outside of the blood and not collecting enough blood in the tube, resulting in unusable samples. Many patients requiring a BC also have a peripheral intravenous catheter ("catheter") but these are not normally used for blood sampling. This means that patients receive many painful needles for both catheter insertion and blood sampling. There is a needle-free blood collection device (PIVO Pro) which can be used with a catheter to collect a blood sample.

The goal of the PIVO Trial is to see if using the PIVO Pro for blood culture sample collection will have a lower amount of contamination than the usual method of blood sample collection. Patients 18 and older at 3 emergency departments will be included. Research nurses will look for patients in emergency who need a blood culture sample taken and they will be asked if they want to be involved in the trial. Half of the participants will use the PIVO Pro to take their blood sample and half will have the usual way of collecting blood.

Participants do not have to do anything specifically for the trial. Information about the blood collection and results of the blood culture will be collected from the medical records and recorded for the trial.

Detailed Description

The PIVO™ Pro Needle-free Blood Collection Device (Becton, Dickinson and Company; Franklin Lakes) has been available for around a decade and involves advancing a flexible internal flow tube through the patient's Peripheral Intravenous Catheter (PIVC) to access a fresh blood sample beyond the PIVC tip. There is supporting evidence that PIVO is comparable to venepuncture for yielding non-Blood Culture (BC) samples without haemolysis and clotting and with equivalent laboratory values; does not negatively impact PIVC dwell time or replacement rates; decreases preanalytical errors and PIVC replacement; improves the rate and degree of haemolysis in comparison to venepuncture and central line collection; and reduces the prevalence of hospital-onset bacteraemia. However, there are limitations to previous research. Theoretically, for newly inserted PIVCs, the PIVO Pro will bypass a PIVC contaminated on insertion through the skin, to collect a clean blood sample from beyond the tip while also avoiding complications associated with PIVC blood draw. While the PIVO Pro is used in some hospitals as part of standard care, there is a need to confirm results relating to BCs in a randomized controlled trial (RCT).

The aim of this trial is to examine whether use of the PIVO Pro at initial PIVC start, compared to standard practice, decreases BC draw contamination rates.

Based on the aim, the primary objective is to compare the efficacy of the PIVO Pro with initial PIVC start for reducing contaminated BC episodes, to standard practice for BC set draw. 1148 adult participants will be randomised into the trial.

The secondary objectives are to:

1. Compare the effect of the PIVO Pro with initial PIVC start on fill volume of BC bottles, to standard practice for BC set draw.

2. Compare the efficacy of the PIVO Pro with initial PIVC start for improving the overall quality of BC set samples (composite of non-contamination and adequate fill volume), to standard practice for BC set draw.

3. Compare the efficacy of (i) the PIVO Pro (ii) venepuncture, and (iii) draw from initial PIVC start for BC set draw to achieve non-contamination and adequate fill volume

4. Compare the efficacy of the PIVO Pro with initial PIVC start for reducing antibiotic use, to standard practice for BC set draw.

At one hospital site, a sub-study will be conducted to compare PIVC failure outcomes following BC draw with the PIVO Pro with initial PIVC start, to BC set draw directly from a PIVC. The aim of the sub-study is to compare the rate of thrombus development and narrowing of vessel diameter (mm) in those participants that develop PIVC-associated complications versus those participants who do not.

Conditions

Blood Culture Contamination; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

PIVO-Pro Intervention arm

In the PIVO Pro arm blood culture (BC) sets will also be collected following standard practice, with the addition of PIVO Pro use to draw one BC set from a newly inserted short peripheral intravenous catheter (PIVC). All steps of care will follow standard practice, with use of the PIVO Pro an additional step. Any further BC sets taken at the same time will be collected from a different body location using venepuncture performed as per standard practice. The PIVO Pro BC collection will follow a set procedure, with all steps performed using aseptic technique

Group Type: EXPERIMENTAL

PIVO-Pro needle-free blood collection device

Intervention Type: DEVICE

The PIVO™ Pro Needle-free Blood Collection Device advances a flexible flow tube through the intravenous catheter to access optimal blood draw conditions, overcoming traditional hurdles to collect high-quality, reliable blood samples.

Control arm

In the control arm, all blood culture (BC) sets will be collected using standard practice (typically 1 each for venepuncture/draw from a newly inserted peripheral intravenous catheter).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PIVO-Pro needle-free blood collection device

The PIVO™ Pro Needle-free Blood Collection Device advances a flexible flow tube through the intravenous catheter to access optimal blood draw conditions, overcoming traditional hurdles to collect high-quality, reliable blood samples.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Blood culture requested due to suspected bloodstream infection
• Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)

Exclusion Criteria

• Patients who have already commenced intravenous antimicrobial medications in the emergency department

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Becton, Dickinson and Company

INDUSTRY

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Rickard

Role: PRINCIPAL_INVESTIGATOR

The University of Queensland

Locations

Caboolture Hospital

Caboolture, Queensland, Australia

Site Status: RECRUITING

Redcliffe Hospital

Redcliffe, Queensland, Australia

Site Status: RECRUITING

The Gold Coast University Hospital

Southport, Queensland, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Andrea Valks

Role: CONTACT

PIVO@uq.edu.au

+61 7 3346 6012

Claire Rickard

Role: CONTACT

c.rickard@uq.edu.au

Facility Contacts

Karen Furlong

Role: primary

Karen.Furlong2@health.qld.gov.au

+61 7 5433 8888

Jason Chan

Role: primary

Jason.Chan@health.qld.gov.au

+61 7 3883 7777

Gerben Keijzers

Role: primary

gerben.keijzers@health.qld.gov.au

+61 1300 744 284

Other Identifiers

IPVA_24.01

Identifier Type: -

Identifier Source: org_study_id