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

NCT ID: NCT05763186

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-18
• Study Completion Date: 2026-05-31

Brief 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 further peripheral puncture in people who generally do not have optimal venous capital.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sampling

• 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.

Group Type: EXPERIMENTAL

Sampling

Intervention Type: OTHER

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 rinsing

• 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.

Group Type: EXPERIMENTAL

Sampling and rinsing

Intervention Type: OTHER

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.

Interventions

Sampling

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.

Intervention Type: OTHER

Sampling and rinsing

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Carrier of PiccLine one way polyurethane

3. Hospitalized in a clinical hematology unit This criterion minimises patient and practice heterogeneity.

4. PiccLine placement not older than 48 hours

5. Injection of at least one solution

6. Affiliated to a social security scheme

7. Having signed a free, informed and written consent

Exclusion Criteria

1. Anemia below the transfusion threshold (hemoglobin level < 7 g/dL) in relation to the patient's pathology

2. Parenteral nutrition

3. Peripheral venous sampling not possible (insufficient venous capital)

4. Protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), breastfeeding woman and minor).

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

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Geffray

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

CHU Rennes

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas Mevel

Role: CONTACT

dri@chu-rennes.fr

02 99 28 25 55

Anne Ganivet

Role: CONTACT

anne.ganivet@chu-rennes.fr

02 99 28 25 55

Facility Contacts

Eric Geffray

Role: primary

Other Identifiers

2022-A01383-40

Identifier Type: OTHER

Identifier Source: secondary_id

35RC22_9907-2_PiccLine

Identifier Type: -

Identifier Source: org_study_id