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

Hematology Clinical Trial

— PiccLine  

Official title:

The Right Amount of Purge Useful for Blood Sampling on PiccLine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05763186
• Other study ID #: 35RC22_9907-2_PiccLine
• Secondary ID: 2022-A01383-40
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: Nicolas Mevel
• Phone: 02 99 28 25 55
• Email: dri[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hematology

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		during 2 days follow-up