Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000313033
Ethics application status
Approved
Date submitted
14/04/2010
Date registered
20/04/2010
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of platelet activation and function in different haematological disorders pre and post treatment using flow cytometry and extracellular regulatory kinase pathway
Scientific title
Study evaluating platelet activation and function, and the
extracellular regulatory kinase pathway in haematological
disorders pre and post treatment using flow cytometry
Secondary ID [1] 1615 0
Nil
Universal Trial Number (UTN)
Trial acronym
PAF-ERK Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Platelet activation and function pre and post treatment in haematological disorders 243522 0
Condition category
Condition code
Blood 239822 239822 0 0
Haematological diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Platelet function analysis by flow cytometry in patients, including those with malignant haematological disorders e.g. leukaemia, lymphoma and multiple myeloma over a period of 4 years in total.
Intervention code [1] 241134 0
Not applicable
Comparator / control treatment
Age and sex matched control without haematological abnormalities
Control group
Active

Outcomes
Primary outcome [1] 240585 0
Platelet function will be assessed by flow cytometry
Timepoint [1] 240585 0
Before the treatment (at time of diagnosis of the disease) as a baseline investigation as well as 30, 60, 90 and 150 days from start of treatment
Secondary outcome [1] 263885 0
Association between platelet dysfunction and different haematological disorders
Timepoint [1] 263885 0
6 months post recruitment

Eligibility
Key inclusion criteria
Patients including those with malignant haematological disorders e.g. leukaemia, lymphoma and multiple myeloma will be recruited on a voluntary basis over a period of 3 years. While age and sex matched controls will be chosen as healthy volunteers as well as patients without any haematological disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant and the human
foetus
Children and/or young people (ie. <18 years)
People in existing dependent or unequal
relationships
People with a cognitive impairment, an
intellectual disability or a mental illness
People who may be involved in illegal activity

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The intended PhD candidate who was assigned to conduct the study had unfortunate and unforeseeable circumstances therefore, it was unable to deliver the study as planned.
Date of first participant enrolment
Anticipated
20/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256815 0
Charities/Societies/Foundations
Name [1] 256815 0
Clifford Craig Medical Reaserch Foundation
Country [1] 256815 0
Australia
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Charles street,Launceston,
Tasmania, 7250, Australia
Country
Australia
Secondary sponsor category [1] 256096 0
University
Name [1] 256096 0
School of Human Life Sciences, University of Tasmania
Address [1] 256096 0
Locked Bag 1320 Launceston Tasmania 7250, Australia
Country [1] 256096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243635 0
Tasmania Health & Medical Human Research Ethics Committee
Ethics committee address [1] 243635 0
School of Human Life Sciences
University of tasmania
Launceston TAS 7250
Ethics committee country [1] 243635 0
Australia
Date submitted for ethics approval [1] 243635 0
Approval date [1] 243635 0
12/03/2010
Ethics approval number [1] 243635 0
H10690

Summary
Brief summary
Although most patients with different haematological disorders present with either bleeding or clotting, there is little known about how patients develop these complications and what risk factors are involved.

Platelets are an essential component of haemostais to stop bleeding and also in case of their activation may give rise to thrombosis.

So it is important to study the role of platelet-function and activation in the patients who are diagnosed with different haematological disorders/cancers and receiving treatment.

Studying platelets function and activation with various new techniques will give us a better understanding of platelets activity in haematological malignancies such as leukaemia, lymphoma, myeloma or other haematological disorders who present to the Launceston General Hospital (LGH), Tasmania, Australia.

With the help of the Flow Cytometer and also as a part of PhD degree at University of Tasmania (UTAS), School of Human Life Sciences, we are aiming to establish different methods of studying platelets activation and function in different haematological malignancies in order to examine the theory of these malignancies and rheir association with platelet activation and or dysfunction.

Significance of the Project:
The availability of fluorescent monoclonal antibodies and probes provides a powerful tool for the investigation of platelet function by flow cytometry. To date, most platelet function analysis by flow cytometry has focused on the involvement of platelets in thrombotic disorders and acute coronary syndromes. One area where research has been limited is in oncology patients, including those with malignant e.g. leukaemia, lymphoma, multiple myeloma, and benign e.g. immuno thrombocytopenia and thrombocytopenic purpura, haematological disorders, where patients usually present with either bleeding or thrombosis symptoms. It is well documented that bleeding is quite common in these patients often leading to more intensive platelet intervention and sometimes poorer prognosis. Thrombocytopenia is usually evident due to the late diagnosis of disease with subsequent marrow replacement or as a consequence of the treatment. However, the effect of platelet dysfunction may also contribute more significantly than is currently known.

Patients with haematological disorders who bleed often receive platelet transfusions. Although this approach usually rectifies the bleeding to suggest the defect is quantitative, it is not known whether abnormal platelet function also contributes to the bleeding diathesis in these patients. Indeed, this is yet to be corroborated given that donor platelets are initially healthy and unaffected when transfused so offer both volume and functionality to the patient before disease or drug regimens have any affect on them.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30055 0
Address 30055 0
Country 30055 0
Phone 30055 0
Fax 30055 0
Email 30055 0
Contact person for public queries
Name 13302 0
Assoc. Prof Khalafallah
Address 13302 0
Department of Haematology
Launceston General Hospital
Charles Street
Launceston Tas 7250
Country 13302 0
Australia
Phone 13302 0
+610417324623
Fax 13302 0
+6103 63487133
Email 13302 0
[email protected]
Contact person for scientific queries
Name 4230 0
Assoc. Prof Khalafallah
Address 4230 0
Department of Haematology
Launceston General Hospital
Charles Street
Launceston Tas 7250
Country 4230 0
Australia
Phone 4230 0
+610417324623
Fax 4230 0
+6103 63487133
Email 4230 0
[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.