Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000782336p
Ethics application status
Not yet submitted
Date submitted
17/05/2017
Date registered
29/05/2017
Date last updated
29/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Will a finger-prick blood full blood count test be as effective and more efficient than a lab blood test?
Scientific title
Evaluation of a point of care full blood count analyser in the outpatient Haematology clinic.
Secondary ID [1] 291979 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Full blood count testing 303322 0
Low blood counts 303323 0
Condition category
Condition code
Blood 302763 302763 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be testing the point of care analyser against the current standard lab analyser in obtaining full blood counts for Haematology patients. There will be an emphasis on low blood counts as this is where decisions are made. The patient will have their regular venous blood test (standard care) and have and ADDITIONAL finger-prick blood test ('intervention'). The finger-prick test will take under ten minutes and will be peformed by a doctor or nurse trained to do so. It will occur in the clinic that the patient would attend anyway, so that the patient would be minimally inconvenienced.
Intervention code [1] 298101 0
Diagnosis / Prognosis
Comparator / control treatment
There will not be a separate control group. The same individual having the finger-prick blood test would also have had a venous blood test for the lab. This would be obtained by venepuncture or from a catheter and performed either at the lab or by a nurse in clinic.
Control group
Active

Outcomes
Primary outcome [1] 302151 0
Comparison of full blood count (Hb, platelets, white cell count and neutrophils) between the finger prick (capillary) test and the lab (venous) blood test. These will be compared using statistical analysis to obtain a coefficient of variance (closer to 1 = more similar results). This is a composite primary outcome.
Timepoint [1] 302151 0
The venous blood test will be obtained prior to the clinic visit and the finger prick blood test will be obtained at the clinic visit (less than two hours after the venous blood test). The data will be obtained and will be analysed over several weeks during and after the completion of the data collection phase of the study. As the results will not alter patient care (although hopefully might enhance future patient care), the results do not need to be analysed in order to provide current standard of care. The aim is for all data to be analysed by one year after the first patient is enrolled.
Secondary outcome [1] 334972 0
Assessment of patient satisfaction with comparison of the venous blood test and the finger prick blood test. To assess this, patients will be provided with a brief questionnaire that has been designed for this study. It will contain only 1-2 questions.
Timepoint [1] 334972 0
Following both interventions - either at the clinic or at the next clinic visit (the patients are usually seen daily).

Eligibility
Key inclusion criteria
Age over 18 years
Haematology patient competent to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2017
Actual
Date of last participant enrolment
Anticipated
1/02/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 8907 0
New Zealand
State/province [1] 8907 0

Funding & Sponsors
Funding source category [1] 296489 0
Hospital
Name [1] 296489 0
Palmerston North Hospital
Country [1] 296489 0
New Zealand
Primary sponsor type
Individual
Name
Nilofer D'Sousa
Address
c/o Clinical Haematology
Palmerston North Hospital
50 Ruahine Street
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 295446 0
Commercial sector/Industry
Name [1] 295446 0
Elitech Limited
Address [1] 295446 0
PO Box 128016
Remuera
Auckland 1541
Country [1] 295446 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297710 0
HDEC NZ
Ethics committee address [1] 297710 0
Ethics committee country [1] 297710 0
New Zealand
Date submitted for ethics approval [1] 297710 0
12/06/2017
Approval date [1] 297710 0
Ethics approval number [1] 297710 0

Summary
Brief summary
We are conducting a study to compare the results available from a finger-prick blood test at the bedside or in the clinic room, to the standard lab blood test for full blood count testing. The aim of the study is to find out whether the results obtained from both tests are similar enough that the finger prick test can be used instead of the lab test. If this is the case, then in some situations, a finger prick test (with results available almost immediately) can replace the lab test. We believe that the results will be similar enough and we also believe that the finger prick test will be preferred by patients due to the ease of the test and the rapid availability of results.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1725 1725 0 0
/AnzctrAttachments/372963-CONSENT FORM POCT study .docx (Participant information/consent)
Attachments [2] 1726 1726 0 0
/AnzctrAttachments/372963-PROTOCOL for Point of Care Testing of Full Blood Count.docx (Protocol)
Attachments [3] 1727 1727 0 0
/AnzctrAttachments/372963-Scientific review for POCT CBC study.docx (Supplementary information)

Contacts
Principal investigator
Name 74910 0
Dr Nilofer D'Sousa
Address 74910 0
Clinical Haematology
Palmerston North Hospital
50 Ruahine Street
Palmerston North 4442
Country 74910 0
New Zealand
Phone 74910 0
+64 6 3508550
Fax 74910 0
+64 6 3508551
Email 74910 0
Nilofer.D'[email protected]
Contact person for public queries
Name 74911 0
Nilofer D'Sousa
Address 74911 0
Clinical Haematology
Palmerston North Hospital
50 Ruahine Street
Palmerston North 4442
Country 74911 0
New Zealand
Phone 74911 0
+64 6 3508550
Fax 74911 0
+64 6 3508551
Email 74911 0
Nilofer.D'[email protected]
Contact person for scientific queries
Name 74912 0
Nilofer D'Sousa
Address 74912 0
Clinical Haematology
Palmerston North Hospital
50 Ruahine Street
Palmerston North 4442
Country 74912 0
New Zealand
Phone 74912 0
+64 6 3508550
Fax 74912 0
+64 6 3508551
Email 74912 0
Nilofer.D'[email protected]

No information has been provided regarding IPD availability


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.