Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)
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)
The University of Queensland
1,148 participants
Aug 18, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Blood culture requested due to suspected bloodstream infection
- Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)
Exclusion Criteria1
- Patients who have already commenced intravenous antimicrobial medications in the emergency department
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Interventions
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06806709