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HematologyPiccLineNCT05763186

The Right Amount of Purge Useful for Blood Sampling on PiccLine (PiccLine)

A study testing Sampling and Sampling and rinsing in people with Hematology, run by Rennes University Hospital at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An increasing number of patients are receiving central lines, including PiccLine systems for the administration of therapeutics and nutrition. Although these systems are not theoretically intended for blood collection, nurses prefer them as a puncture site when they are in place in their patients, saving them from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematology
What is being tested?
Sampling and Sampling and rinsing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteFrance
Study dates
18 May 2024to May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years
  • Carrier of PiccLine one way polyurethane
  • Hospitalized in a clinical hematology unit This criterion minimises patient and practice heterogeneity.
  • PiccLine placement not older than 48 hours
  • Injection of at least one solution
  • Affiliated to a social security scheme
  • Having signed a free, informed and written consent

Who cannot join

  • Anemia below the transfusion threshold (hemoglobin level < 7 g/dL) in relation to the patient's pathology
  • Parenteral nutrition
  • Peripheral venous sampling not possible (insufficient venous capital)
  • Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), breastfeeding woman and minor).

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • CHU Rennes

    Rennes

    Eric Geffray

    Recruiting

Other trials in France

About this study

Official title: The Right Amount of Purge Useful for Blood Sampling on PiccLine

An increasing number of patients are receiving central lines, including PiccLine systems for the administration of therapeutics and nutrition.

Although these systems are not theoretically intended for blood collection, nurses prefer them as a puncture site when they are in place in their patients, saving them from further peripheral puncture in people who generally do not have optimal venous capital.

Read more

It is essential to purge the tubing in place in the patient and filled with infusion solution before drawing blood. Although the dead volume of the tubing used does not exceed 2mL, the volume of purging required before filling tubes for the laboratory appears to be much greater. Anecdotal evidence suggests a useful volume of 20ml but this has never been clearly demonstrated. In addition, the Biochemistry laboratory regularly sees blood samples diluted with perfusion solution, as evidenced by biochemical assays, leading to the cancellation of analyses received in the laboratory and a new sample being taken. This increases blood spoliation for these often already anaemic patients.

There is no consensus in the literature on recommendations for such sampling in PiccLine patients:

  • The CLSI1 (Clinical and Laboratory Standart Institute), a non-governmental organisation, issued sampling recommendations in 2017 that were taken up by Becton Dickinson2, a supplier of blood collection tubes. These recommendations include:
  • Rinse with 10 ml of 0.9% NaCl
  • Then a purge of 3 to 11 ml (depending on the analysis sought)
  • English-language articles3,4,5,6,7 show purge volumes ranging from 3 to 6 ml with significantly different sampling methods (rinsing or not).

The investigators therefore note a discrepancy between the sampling practices of the university hospital and the recommendations of the CLSI. In fact, the investigators noted a lack of rinsing prior to purging, which could explain the difference between 20 and 3 ml. This raises the issue of protocolisation of this type of sampling in order to standardise practices.

A consultation of other hospitals, carried out beforehand, enabled us to note that French practices are not in agreement with these recommendations. The management of the Rennes University Hospital as well as the Haute Autorité de Santé were contacted in order to confirm that no normative document had been published or was being drafted on this subject.

The fields of study are: sampling practices on PiccLine, the pre-analytical phase in medical biology.

Conditions
Hematology
Being tested
Sampling, Sampling and rinsing
Keywords
PiccLine, blood collection, purge

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SamplingOther

    Comparison of the results of the biological examinations obtained on the 6 tubes collected on the PiccLine with the results of the biological examinations obtained on the peripheral sample.

  • Sampling and rinsingOther

    Comparison of the results of the biological examinations obtained on the 6 tubes collected on the PiccLine with the results of the biological examinations obtained on the peripheral sample.

Study groups in NCT05763186
Study groupRoleWhat they receive
SamplingExperimental* On the PiccLine: a collection of 6 consecutive heparinized tubes with 3.5ml gel corresponding to the usual purge volume * In the periphery : one 3.5ml heparin-gel tube as a reference.
Receives: Other: Sampling
Sampling and rinsingExperimental* On the PiccLine: a 10 ml pre-rinsing with 0.9% NaCl and then a sampling of 6 consecutive heparinized tubes with 3.5ml gel corresponding to the usual purge volume. * In the periphery: one 3.5 ml heparin-gel tube as a reference.
Receives: Other: Sampling and rinsing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lowest purge volume to obtain a biological result in the PiccLine sample that matches the peripheral sample taken from the same patient at the same time for the following assays: - Sodium, potassium and chlorine - Creatinine - Glucose

    Measured: during 2 days follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start18 May 2024
  3. Primary completionNov 2025 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763186
Sponsor's protocol ID
35RC22_9907-2_PiccLine
Other IDs
2022-A01383-40
Acronym
PiccLine
Status last verified
Sep 2024
First submitted
28 Feb 2023
Last updated
21 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Sampling and Sampling and rinsing in people with Hematology, run by Rennes University Hospital at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas Mevel (02 99 28 25 55, dri@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lowest purge volume to obtain a biological result in the PiccLine sample that matches the peripheral sample taken from the same patient at the same time for the following assays: - Sodium, potassium and chlorine - Creatinine - Glucose (time frame: during 2 days follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.

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