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

Study acronym: PiccLine
StatusUnknown
PhaseNot applicable
Started
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Record status
This record was last updated May 21, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary completion date: Nov 2024 to Nov 2025
    • Enrollment target: 60 to 66
    • Study completion date: May 2025 to May 2026
    v5
  3. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Oct 2023 to Nov 2024
    • Start date changed from estimate of Sep 2023 to May 18, 2024
    • Study completion date: Apr 2024 to May 2025
    • Site details revised
  4. Notable Start date: Apr 2023 to Sep 2023v3
  5. Minor Interventions: biological measurement (Other) to Sampling (Other), Sampling and rinsing (Other)v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05763186
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)
Hematology
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov