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

• Conditions: Alcohol Abuse

• Registration Number: NCT04557631
• Lead Sponsor: University Hospital, Lille

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-23
• Study Start: 2021-09
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of patients with a Peth concentration greater than 200 µg/L	at the end of study (at 6 months)

Secondary Outcome Measures

Name	Time	Method
the concentration of Peth in blood in DBS	between T0 and 4 weeks and the end of study (at 6 months)	decrease expressed as a percentage of the initial concentration, in the Dried Blood Spot (DBS)
the concentration of Peth in blood in ambiant temperature	between T0 and 96h and the end of study (at 6 months)	descrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and stored at room temperature,
the concentration of Peth in blood at 4°C	between T0 and 96h and the end of study (at 6 months)	ecrease expressed as a percentage of the initial concentration, in the primary blood tube (citrate tube) and at 4°C.