Clinical trial NCT06806709: Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
Official title: Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (PIVO Pro): An Adaptive Group Sequential Randomized Controlled Trial (The PIVO Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Culture Contamination
Infection
Keywords: PIVO Pro
Reducing blood culture contamination
Needle-less blood draw
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
First posted: 2025-02-04
Enrollment: 1148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Blood culture draw success without contamination.
timeFrame: Measured at baseline
Secondary outcomes:
measure: Blood culture draw underfill
timeFrame: Measured at baseline
measure: Blood culture set quality
timeFrame: Measured at baseline
measure: Antibiotic use
timeFrame: Within 1 week of baseline.
Other outcomes:
Locations:
city: Caboolture
country: Australia
facility: Caboolture Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Southport
country: Australia
facility: The Gold Coast University Hospital
state: Queensland
Study officials:
affiliation: The University of Queensland
name: Claire Rickard
role: PRINCIPAL_INVESTIGATOR
References: