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Trial registered on ANZCTR


Registration number
ACTRN12617001237370
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
24/08/2017
Date last updated
31/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Utility of Whole Blood Point of Care Beta human Chorionic Gonadotrophin (BhCG) Testing using Urine Pregnancy Assay
Scientific title
Utility of Whole Blood Point of Care BhCG Testing on Urine Pregnancy Assay - a comparison of time taken to obtain results from whole blood point of care BhCG testing versus lab serum BhCG and urine point of care BhCG testing in female patients presenting to the Emergency Department who require pregnancy status checked
Secondary ID [1] 291838 0
Nil known
Universal Trial Number (UTN)
U1111-1196-2179
Trial acronym
Linked study record
Universal Trial Number (UTN) U1111-1194-3181 - the studies are linked, and will be run concurrently.
ACTRN registration number: ACTRN12617000656336

Health condition
Health condition(s) or problem(s) studied:
pregnancy 303084 0
Condition category
Condition code
Reproductive Health and Childbirth 302542 302542 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of time taken to obtain results from urine and whole blood testing using point of care B-hCG testing cartridges, and blood samples sent to the lab for serum testing.
Blood drawn from the patient will be sent to the lab for testing as per our usual practice. The time taken to obtain a result since the patient's presentation to the Emergency Department will be calculated. Three drops from that sample drawn will be tested using the bedside BhCG test cartridge, and the time taken to obtain a result from that since the patient's presentation will be calculated. When the patient is able to provide a urine sample, the urine will be tested using the bedside BhCG test cartridge, and the time taken to obtain a result from that since the patient's presentation will be calculated. These times will then be compared to find which is the most efficient method to obtain a BhCG result, and if there is a difference depending on time of day of patient presentation.
Clinicians are likely to be aware of the results from the urine and whole blood point of care tests, but only the lab serum B-hCG result will be used to determine patient care.
Intervention code [1] 298962 0
Diagnosis / Prognosis
Comparator / control treatment
Urine and blood samples from each patient will be compared against each other for time taken to obtain results. The reference standard will be the time taken to obtain a result from a blood sample sent to the lab (serum BhCG result). The comparator tests will be whole blood tested on the point of care BhCG test cartridge, and urine tested on the point of care BhCG test cartridge.
Control group
Active

Outcomes
Primary outcome [1] 301964 0
Time taken (since patient presentation) to obtain the B-hCG result from whole blood on point of care testing B-hCG cartridge compared to urine on point of care testing B-hCG cartridge.
Timepoint [1] 301964 0
During patient's stay in the Emergency Department.
Primary outcome [2] 301965 0
Time taken (since patient presentation) to obtain the B-hCG result from whole blood on point of care testing B-hCG cartridge compared to the blood sample sent to the lab for serum testing.
Timepoint [2] 301965 0
During the patient's stay in the Emergency Department.
Secondary outcome [1] 334389 0
None
Timepoint [1] 334389 0
None

Eligibility
Key inclusion criteria
Females of reproductive age (18-50) presenting to the Mater Adults Hospital Emergency Department
Patients who will have their pregnancy status tested as part of their usual care given their presenting complaint
Minimum age
18 Years
Maximum age
50 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who do not consent or withdraw consent from the study.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size:
n1 + n2 = (4o2 (Z 1-a/2 + Z 1-ß)2) / (µ1 - µ2)

o = sample mean = 130 mins (calculated based on an analysis of times taken to obtain results from whole blood sent to the lab for 50 sequential patients)
Z 1-a/2 = 1.96 for a = 0.05
Z 1-ß = 1.282 for Power = 1-ß = 0.9
µ1 - µ2 = difference to be detected = 15 mins

n1 + n2 = 630 --> n = number of observations to be done in each group
--> 315 participants required as 2 observations for comparison will be done on each participant

This is the calculation for the comparison between times taken to get a result from whole blood being used on the point of care B-hCG test cartridge and the blood sample sent to the lab for a serum B-hCG result. At this stage, the times taken to obtain a urine result from patients is not clearly recorded, so it is not possible to calculate a sample mean. A post-hoc analysis will be done for the comparison between times taken to get a result from whole blood being used on the point of care B-hCG test cartridge and urine being used on the point of care B-hCG test cartridge to ensure that the sample size is adequate to power the study to detect a 15 minute difference.

Assuming a similar sample mean for time taken to obtain a urine BhCG result, 315 participants would be required to make that comparison as well.

--> participants require for the study = 630

This is being done concurrently with a study to validate the sensitivity and specificity of whole blood being used on the point of care B-hCG test cartridge. 1098 patients will be recruited for the study.


Analysis:
A paired T-test will be done to determine if there is a significant difference between the mean times to results using each B-hCG testing method of greater than 15 minutes. The times to results using whole blood on the point of care B-hCG test cartridge will be compared with the times to results from whole blood samples sent to the lab for serum B-hCG testing. The times to results using whole blood on the point of care B-hCG test cartridge will be compared with times to results using urine on the point of care B-hCG test cartridge.

The results will also be divided into patient presentations by shift times (Day = 0800-1600,Evening = 1600-0000, Night = 0000-0800). A further analysis will be done to see if the efficiency of testing methods changes depending on the time of patient presentation.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Study was approved by Ethics and Governance, but the Pathology department would not support the study. It would require a significant protocol change to do the study without Pathology support (includes the phlebotomists), which would result in study outcomes not reflecting our actual clinical practice.
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)
QLD
Recruitment hospital [1] 8521 0
Mater Adult Hospital - South Brisbane
Recruitment postcode(s) [1] 16614 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 296336 0
Hospital
Name [1] 296336 0
Mater Adult Hospital Brisbane Emergency Department
Address [1] 296336 0
Raymond Terrace
South Brisbane
QLD 4101
Country [1] 296336 0
Australia
Primary sponsor type
Hospital
Name
Mater Adult Hospital Brisbane Emergency Department
Address
Raymond Terrace
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 295265 0
None
Name [1] 295265 0
Address [1] 295265 0
Country [1] 295265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297567 0
Mater Health Services Research Ethics
Ethics committee address [1] 297567 0
Room 294, Level 2, Aubigny Place
Raymond Terrace
South Brisbane Qld 4101
Ethics committee country [1] 297567 0
Australia
Date submitted for ethics approval [1] 297567 0
20/06/2017
Approval date [1] 297567 0
09/01/2018
Ethics approval number [1] 297567 0
HREC/17/MHS/48

Summary
Brief summary
This study aims to investigate the utility of the use of whole blood for point of care testing for B-hCG to rapidly differentiate pregnant and non-pregnant patients. This is important in time-critical conditions such as ruptured ectopic pregnancy. It would also expedite things in the situation where medical imaging involving ionising radiation is delayed until pregnancy can be excluded.
The current testing options are a urine point of care test, or a serum sample sent to the
pathology lab. The point of care test pack inserts state that whole blood cannot be used with them, but in practice they have been used that way and expedited decision-making. A convenience sample of female patients of reproductive age presenting to the Emergency Department who would typically have their pregnancy status checked, will be recruited to the study. A whole blood B-hCG (point of care), a urine B-hCG (point of care), and a serum sample for quantitative hCG will be tested.
The blood sample will be sent to pathology for a quantitative serum B-hCG result, and will be used as the standard for comparison. A result of <1.2 units/L is a negative pregnancy test. The results from the urine and whole blood point of care tests will be compared against this, to determine their sensitivity and specificity in a separate analysis.
The time taken to obtain a result from the point of care B-hCG testing using urine and whole blood will be compared against the time taken to obtain a result from the sample sent to the lab. We will then be able to compare the differences between length of time taken to obtain a urine or blood sample, and the differences between length of time taken to obtain test results for each of these samples.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74462 0
Dr Xiu Lee
Address 74462 0
Emergency Department
Mater Adult Hospital Brisbane
Raymond Terrace
QLD 4101
Country 74462 0
Australia
Phone 74462 0
+61 7 3163 8111
Fax 74462 0
Email 74462 0
xiu.lee@mater.org.au
Contact person for public queries
Name 74463 0
Dr Xiu Lee
Address 74463 0
Emergency Department
Mater Adult Hospital Brisbane
Raymond Terrace
QLD 4101
Country 74463 0
Australia
Phone 74463 0
+61 7 3163 8111
Fax 74463 0
Email 74463 0
xiu.lee@mater.org.au
Contact person for scientific queries
Name 74464 0
Dr Xiu Lee
Address 74464 0
Emergency Department
Mater Adult Hospital Brisbane
Raymond Terrace
QLD 4101
Country 74464 0
Australia
Phone 74464 0
+61 7 3163 8111
Fax 74464 0
Email 74464 0
xiu.lee@mater.org.au

No data has been provided for results reporting
Summary results
Not applicable