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Trial registered on ANZCTR


Registration number
ACTRN12622001497796p
Ethics application status
Submitted, not yet approved
Date submitted
16/11/2022
Date registered
29/11/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
29/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the usefulness of phosphatidylethanol (PEth) measurements to detect alcohol consumption in Emergency Department patients who are being treated for suspected alcohol-related injury.
Scientific title
Clinical Utility of Phosphatidylethanol (PEth) measurements to detect alcohol consumption in Emergency Department patients who are being treated for suspected alcohol-related injury.
Secondary ID [1] 308419 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alcohol-related injury
 328224 0
Condition category
Condition code
Emergency medicine 325273 325273 0 0
Other emergency care
Injuries and Accidents 325291 325291 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project is a single-arm non-interventional quantitative study to investigate the clinical utility of PEth as a sensitive marker for alcohol consumption. The study will be conducted at Sir Charles Gairdner Hospital (SCGH), Nedlands, and will survey the ED population for a period of 12 months. All subjects who present to the ED and have a serum alcohol test requested by the clinician between January 2023 and January 2024 will be considered for inclusion in the study. The study consists of a single timepoint with no participant follow-up. Subjects who present to the ED and have a serum alcohol test requested by a treating clinician will be considered for inclusion in the study.

The study will involve the secondary use of routinely collected blood samples that have completed their clinical purposes and are in storage, awaiting disposal. The clinical study is a single time-point (snapshot) experiment, using single specimens taken from patients, where patients will not be contacted, and their treatment will not be affected by the outcome of the research.
Intervention code [1] 324874 0
Diagnosis / Prognosis
Comparator / control treatment
This study is assessing the ability of PEth measurements to detect recent alcohol consumption when routinely applied indicators have not. In this case, the control group will be the originally requested serum alcohol result that has been requested by the treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 333130 0
We want to know whether the PEth test can give us information that the simple blood alcohol test can’t. Specifically, we will determine the number of cases where the PEth test tells us of alcohol use that the blood alcohol test has not revealed, and how often the PEth test fails to pick up alcohol use that is revealed by the blood alcohol test. For this purpose, the outcome measures will be the incidence of any measurable alcohol presence (for the blood alcohol test) and the incidence of PEth presence at a concentration exceeding 20 ng/mL. That is a threshold value suggested by research that we have already done on PEth.

PEth will be measured in whole blood, which will be the residua of routine pathology analyses. Alcohol measurement will be carried out in serum, using a dedicated serum sample..
Timepoint [1] 333130 0
The study has a single timepoint per participant/hospital admission, which is the episode where a serum alcohol test has been requested by the treating clinician.
Primary outcome [2] 333131 0
Correlation of PEth measurements with Gamma-glutamyltransferase (GGT) activity.

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [2] 333131 0
Once only during Emergency Department admission
Primary outcome [3] 333158 0
Correlation of PEth measurements with Alanine aminotransferase (ALT) activity.

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [3] 333158 0
Once only during Emergency Department admission
Secondary outcome [1] 415908 0
Primary outcome [4]

Correlation of PEth measurements with Alkaline Phosphatase (ALP) activity.

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [1] 415908 0
Primary timepoint [4]

Once only during Emergency Department admission
Secondary outcome [2] 416145 0
Primary outcome [5]

Correlation of PEth measurements with blood haematocrit

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [2] 416145 0
Primary timepoint [5]

Once only during Emergency Department admission
Secondary outcome [3] 416146 0
Primary outcome [7]

Correlation of PEth measurements with blood haemoglobin

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [3] 416146 0
Primary timepoint [7]

Once only during Emergency Department admission
Secondary outcome [4] 416147 0
Primary outcome [8]

Correlation of PEth measurements with mean cell volume

Parametric analysis using regression plots and preparation of contingency tables will be used to analyse the data.
Timepoint [4] 416147 0
Primary timepoint [8]

Once only during Emergency Department admission

Eligibility
Key inclusion criteria
- Males and females aged 18 years old and over.
- A serum alcohol test and full blood picture have been requested, and testing has been completed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects who are pregnant.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Preliminary data on the results of alcohol tests requested from the SCGH ED indicates that 54% are positive for alcohol. Power calculations for chi-square comparison indicate that a sample size of 273 specimens will have 80% power to detect a difference of 20% in the incidence of alcohol-positivity and PEth-positivity at a significance level of 0.05. A sample size of 1200, the number expected over the 12-month duration of this study, will substantially exceed this estimate. Interim analyses will be performed after each 50 specimens.

Data presentation will be primarily descriptive, summarising the incidences at which blood alcohol tests and PEth testing concur (either both positive or both negative), the incidence of positive PEth in the presence of negative plasma alcohol and the incidence of negative PEth with positive plasma alcohol. Similar comparisons will be made to MCV, AST, ALP and GGT. Positive values are defined as any measurable presence above lower limit of quantitation for plasma alcohol, > 20 ng/mL for PEth (initially), and > 2SD above population mean for MCV, AST, ALP and GGT. Quantitative results for each test will be summarised as means/medians and SD or IQR, as appropriate to the data distribution.

A comparison will be made between the incidence of ethanol positivity and PEth positivity in the study population using chi square testing. Analyses to follow will compare PEth positive/negative and positive/negative for other alcohol markers (MCV, ALT, ALP GGT). The definition of PEth positivity has been taken from our earlier developmental work that shows all non-drinkers to have PEth concentrations under 20 ng/mL. In exploratory analyses, the definition of PEth positivity will be varied by steps up to 200 ng/mL, to test the utility of definitions of problematic drinking which are under development. The purpose is to test whether positive results (as defined above) on any other the other tests become more likely as the threshold for PEth positivity increases. Cohen’s kappa for agreement between serum ethanol concentration and PEth will be calculated. Depending on the data distribution, Pearson or Spearman correlation will be calculated for the relationship between serum alcohol concentration and PEth concentration. There is no gold standard test for alcohol exposure, so the data will not support construction of informative receiver-operator curves.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/01/2023
Actual
Date of last participant enrolment
Anticipated
14/01/2024
Actual
Date of last data collection
Anticipated
17/01/2024
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23573 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 38995 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312670 0
Government body
Name [1] 312670 0
PathWest Laboratory Medicine
Country [1] 312670 0
Australia
Funding source category [2] 312675 0
Hospital
Name [2] 312675 0
Sir Charles Gairdner Hospital
Country [2] 312675 0
Australia
Primary sponsor type
Government body
Name
PathWest Laboratory Medicine
Address
Locked Bag 2009,
Nedlands,
WA 6009,
Country
Australia
Secondary sponsor category [1] 314307 0
None
Name [1] 314307 0
Address [1] 314307 0
Country [1] 314307 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311973 0
Sir Charles Gairdner / Osborne Park Hospital Group Human Research Ethics Committee
Ethics committee address [1] 311973 0
Sir Charles Gairdner Hospital,
Level 2, A block,
Hospital Ave,
Nedlands, WA 6009
Ethics committee country [1] 311973 0
Australia
Date submitted for ethics approval [1] 311973 0
04/11/2022
Approval date [1] 311973 0
Ethics approval number [1] 311973 0

Summary
Brief summary
We think that we now have a better test for identifying clinically important alcohol use, by measuring an alcohol product, phosphatidiylethanol (PEth), in blood. We want to compare this test with the current standard blood test for alcohol (the blood alcohol level) by running both tests on every blood specimen sent from the emergency department (ED) for alcohol testing in the next 12 months. This is a non-interventional, observational study, consisting of patients whose alcohol consumption is being investigated as a causative factor in illness or injury.
The study will involve the secondary use of routinely collected blood samples that have completed their clinical purposes and are in storage, awaiting disposal. The clinical study is a single time-point (snapshot) experiment, where patients will not be contacted, and their treatment will not be affected by the outcome of the research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123022 0
Mr Daniel White
Address 123022 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
PP Block, Level 1,
QEII Medical Centre.
Hospital Avenue,
Nedlands,
WA 6009,
Country 123022 0
Australia
Phone 123022 0
+61 0863834128
Fax 123022 0
Email 123022 0
daniel.white@health.wa.gov.au
Contact person for public queries
Name 123023 0
Mr Daniel White
Address 123023 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
PP Block, Level 1,
QEII Medical Centre,
Hospital Avenue,
Nedlands,
WA 6009,
Country 123023 0
Australia
Phone 123023 0
+61 0863834128
Fax 123023 0
Email 123023 0
daniel.white@health.wa.gov.au
Contact person for scientific queries
Name 123024 0
Mr Daniel White
Address 123024 0
Department of Clinical Pharmacology & Toxicology,
PathWest Laboratory Medicine,
PP Block, Level 1,
QEII Medical Centre.
Hospital Avenue,
Nedlands,
WA 6009,
Country 123024 0
Australia
Phone 123024 0
+61 0863834128
Fax 123024 0
Email 123024 0
daniel.white@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.