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Clinical Trials/NCT04557631
NCT04557631WithdrawnNot Applicable

Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol

University Hospital, Lille0 sites30 target enrollmentStarted: September 1, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Enrollment
30
Primary Endpoint
Frequency of patients with a Peth concentration greater than 200 µg/L
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

For an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to:

  • to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature.
  • Also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (DBS), depending on temperature (ambient temperature and +4°C)

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to WHO criteria
  • •Person hospitalized for a hospital withdrawal in the addiction service of Lille's hospital, without other distinctions.

Exclusion Criteria

  • •Patient opposing the use of their personal data in the study
  • •Patient subject to protective measures (guardianship or curatorship)
  • •Person deprived of liberty

Outcomes

Primary Outcomes

Frequency of patients with a Peth concentration greater than 200 µg/L

Time Frame: at the end of study (at 6 months)

Secondary Outcomes

  • the concentration of Peth in blood in DBS(between T0 and 4 weeks and the end of study (at 6 months))
  • the concentration of Peth in blood in ambiant temperature(between T0 and 96h and the end of study (at 6 months))
  • the concentration of Peth in blood at 4°C(between T0 and 96h and the end of study (at 6 months))

Investigators

Sponsor
University Hospital, Lille
Sponsor Class
Other
Responsible Party
Sponsor

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Evaluation of the Threshold for the... | Clinical Trial