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Trial registered on ANZCTR


Registration number
ACTRN12619000204145
Ethics application status
Approved
Date submitted
6/02/2019
Date registered
12/02/2019
Date last updated
17/09/2020
Date data sharing statement initially provided
12/02/2019
Date results information initially provided
17/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A study examining the effect of blood and plasma donation on serum per- and poly-fluoroalkyl substances (PFAS) levels in Metropolitan Fire Brigade staff
Scientific title
A randomised controlled trial examining the effect of blood and plasma donation on serum per- and poly-fluoroalkyl substances (PFAS) levels in Metropolitan Fire Brigade staff
Secondary ID [1] 297269 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
per- and poly-fluoroalkyl substances (PFAS) contamination 311371 0
Condition category
Condition code
Public Health 310008 310008 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of three groups.
Group one will donate blood every 12 weeks for 12 months, group two will donate plasma every 6 weeks for 12 months and group three will undergo no intervention.
Participants will have their donations checked by the study coordinator.
Intervention code [1] 313542 0
Treatment: Other
Comparator / control treatment
Participants in the control group will not donate blood or plasma, and will have their PFAS levels reassessed at the end of the study period.
Control group
Active

Outcomes
Primary outcome [1] 318915 0
To identify whether there is a significant change in serum PFOS levels after 12 months of whole blood or plasma donation compared to the control-only group.
Timepoint [1] 318915 0
After 12 months of intervention
Primary outcome [2] 320314 0
To identify whether there is a significant change in serum PFHxS levels after 12 months of whole blood or plasma donation compared to the control-only group.
Timepoint [2] 320314 0
After 12 months of donations
Secondary outcome [1] 366685 0
Changes in serum PFAS (PFOS or PFHxS) levels in each group from post-test to 3-month follow-up.
Timepoint [1] 366685 0
Difference between serum PFAS level after 12 months of intervention and the level a further 3 months later.
Secondary outcome [2] 366686 0
Differences in serum total cholesterol between whole blood donation, plasma donation and control groups.
Timepoint [2] 366686 0
After 12 months of the intervention.
Secondary outcome [3] 366687 0
Differences in serum thyroid stimulating hormone (TSH) levels between whole blood donation, plasma donation and control groups.
Timepoint [3] 366687 0
After 12 months of the intervention.
Secondary outcome [4] 366688 0
Differences in serum bilirubin between whole blood donation, plasma donation and control groups.
Timepoint [4] 366688 0
After 12 months of the intervention.
Secondary outcome [5] 366689 0
Differences in serum creatinine between whole blood donation, plasma donation and control groups.
Timepoint [5] 366689 0
After 12 months of the intervention.
Secondary outcome [6] 366742 0
Differences in serum LDL between whole blood donation, plasma donation and control groups.
Timepoint [6] 366742 0
After 12 months of the intervention.
Secondary outcome [7] 366743 0
Differences in serum HDL between whole blood donation, plasma donation and control groups.
Timepoint [7] 366743 0
After 12 months of the intervention.
Secondary outcome [8] 366744 0
Differences in serum triglycerides between whole blood donation, plasma donation and control groups.
Timepoint [8] 366744 0
After 12 months of the intervention.
Secondary outcome [9] 366745 0
Differences in serum thyroxine (T4) between whole blood donation, plasma donation and control groups.
Timepoint [9] 366745 0
After 12 months of the intervention.
Secondary outcome [10] 366746 0
Differences in serum triiodothyronine (T3) between whole blood donation, plasma donation and control groups.
Timepoint [10] 366746 0
After 12 months of the intervention.
Secondary outcome [11] 366747 0
Differences in serum alanine aminotransferase (ALT) between whole blood donation, plasma donation and control groups.
Timepoint [11] 366747 0
After 12 months of the intervention.
Secondary outcome [12] 366748 0
Differences in serum aspartate aminostransferase (AST) between whole blood donation, plasma donation and control groups.
Timepoint [12] 366748 0
After 12 months of the intervention.
Secondary outcome [13] 366749 0
Differences in serum gamma-glutamyl transferase (GGT) between whole blood donation, plasma donation and control groups.
Timepoint [13] 366749 0
After 12 months of the intervention.
Secondary outcome [14] 366750 0
Differences in serum albumin between whole blood donation, plasma donation and control groups.
Timepoint [14] 366750 0
After 12 months of the intervention.
Secondary outcome [15] 371215 0
Change in serum levels of other PFAS chemicals, this is an exploratory outcome and will include (but is not be limited to) PFOA, PFBS, PFPeS, PFHpS, PFDS, PFBA, PFPeA, PFHxA, PFHpA, PFNA, PFDA, PFUnDA, PFDoDA, PFTrDA, PFTeDA, 4:2 FTS, 6:2 FTS, 8:2 FTS, 10:2 FTS, FOSA 10, MeFOSA, EtFOSA, MeFOSE, EtFOSE, MeFOSAA, EtFOSAA
Timepoint [15] 371215 0
After 12 months and 15 months
Secondary outcome [16] 371216 0
Difference in serum PFOS levels between whole blood and plasma donation.
Timepoint [16] 371216 0
12 months
Secondary outcome [17] 371217 0
Difference in serum PFHxS levels between whole blood and plasma donation.
Timepoint [17] 371217 0
After 12 months of donation

Eligibility
Key inclusion criteria
1. Metropolitan Fire Brigade staff with 10 or more years of previous occupational exposure to PFAS.

2. PFOS levels >=5ng/mL

3. Eligible to donate blood (in accordance with the ARCBS guidelines).

4. Not donated blood in the past 3 months.

5. Signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the trial prior to enrolment.

6. Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical contraindication to blood donation.

2. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and in the judgment of the investigator would make the participant inappropriate for entry into this study.

3. Previous ineligibility to donate blood.

4. Planned travel or extended leave (e.g. >6 weeks) that would prevent access to blood donation facilities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be conducted by the study statistician off-site, and participants will be informed of their group allocation by mail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use covariate-adaptive randomisation to balance participants' sex and blood PFAS levels between the three groups, randomising subjects as the results from the analyses of the baseline PFAS screening are received from the lab.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We would consider a 25% reduction in serum PFAS levels to be significant after 12 months of plasma or whole blood donation. Based on the serum levels of PFHxS, PFOS, and PFOA found in 149 Australian firefighters in Rotander et al. (2015), and a correlation between the assessments at baseline and 12 months (post-test) of r = .6, this corresponds to a standardised effect size of mean difference dz > .31. We would require each group to have 94 participants to have 90% power to detect a 25% reduction in PFAS levels.

In order to test whether plasma donation reduces serum PFAS levels at a faster rate than whole blood donation, we would require each group to have 105 participants at pre-test for 90% power to detect a conventional small effect size (partial eta-squared of .01) difference between the groups from pre-test to post-test.

To further compare the efficacy of plasma donation and whole blood donation to the observation only group (control), a sample of 105 participants per group would provide 80% power to detect the same small effect size (and 90% power to detect partial n squared = .013) after correction for multiple testing.

We have planned our analyses based on intention-to-treat and will use multiple imputation to handle missing data. Our power analyses are conservative to account for the possibility of inflated Type II error and indicate a required total sample size of 315 participants (105 per group). The protocol is designed to allow for up to 10% of participants being lost to follow-up over the life of the project.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 301829 0
Commercial sector/Industry
Name [1] 301829 0
Metropolitan Fire Brigade
Address [1] 301829 0
456 Albert Street
East Melbourne Vic 3002
Country [1] 301829 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd, Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 301572 0
None
Name [1] 301572 0
Address [1] 301572 0
Country [1] 301572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302531 0
Macquarie University; Macquarie University Human Research Ethics Committee (Medical Sciences).
Ethics committee address [1] 302531 0
17 Wally's Walk
Macquarie University
NSW 2109
Ethics committee country [1] 302531 0
Australia
Date submitted for ethics approval [1] 302531 0
16/11/2018
Approval date [1] 302531 0
17/12/2018
Ethics approval number [1] 302531 0
3855

Summary
Brief summary
This is a study to assess the effect of 12 months of blood or plasma donation on serum PFAS levels in a cohort of Metropolitan Fire Brigade (MFB) firefighters.

The purpose of the study is to determine if regular blood donation (i.e. whole blood, or plasma donation) will be effective in reducing serum PFAS levels.

Participants will be randomly allocated into one of the following three groups: a whole blood donation, a plasma donation or an observation only for a 12-month period.

Group 1: Blood donation every 12 weeks

Group 2: Plasma donation every 6 weeks

Group 3: Observation alone

The study will run for a total of 18 months (approximately 3 months screening and randomisation, 12 months intervention and 3 months follow up).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90542 0
Dr Robin Gasiorowski
Address 90542 0
Senior Lecturer, Haematology
Department of Clinical Medicine
2 Technology Place
Macquarie University
NSW 2109
Country 90542 0
Australia
Phone 90542 0
+61 (2) 9812 2981
Fax 90542 0
Email 90542 0
robin.gasiorowski@mq.edu.au
Contact person for public queries
Name 90543 0
Dr Robin Gasiorowski
Address 90543 0
Senior Lecturer, Haematology
Department of Clinical Medicine
2 Technology Place
Macquarie University
NSW 2109
Country 90543 0
Australia
Phone 90543 0
+61 (2) 9812 2981
Fax 90543 0
Email 90543 0
robin.gasiorowski@mq.edu.au
Contact person for scientific queries
Name 90544 0
Dr Robin Gasiorowski
Address 90544 0
Senior Lecturer, Haematology
Department of Clinical Medicine
2 Technology Place
Macquarie University
NSW 2109
Country 90544 0
Australia
Phone 90544 0
+61 (2) 9812 2981
Fax 90544 0
Email 90544 0
robin.gasiorowski@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this study is recruiting from a relatively small, defined population there is concern that individuals may be able to be identified from their IPD, even though it will be de-identified.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary