ANZCTR - Registration

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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]

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

Condition category

Condition code

Blood

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]

Not applicable

Comparator / control treatment

Age and sex matched control without haematological abnormalities

Control group

Active

Outcomes

Primary outcome [1]

Platelet function will be assessed by flow cytometry

Timepoint [1]

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]

Association between platelet dysfunction and different haematological disorders

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig Medical Reaserch Foundation

Address [1]

Fifth Floor,
Launceston General Hospital, Charles street,
Launceston, Tasmania, 7250, Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Launceston General Hospital

Address

Charles street,Launceston,
Tasmania, 7250, Australia

Country

Australia

Secondary sponsor category [1]

University

Name [1]

School of Human Life Sciences, University of Tasmania

Address [1]

Locked Bag 1320 Launceston Tasmania 7250, Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health & Medical Human Research Ethics Committee

Ethics committee address [1]

School of Human Life Sciences
University of tasmania
Launceston TAS 7250

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

12/03/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc. Prof Khalafallah

Address

Department of Haematology
Launceston General Hospital
Charles Street
Launceston Tas 7250

Country

Australia

Phone

+610417324623

Fax

+6103 63487133

alhossain@yahoo.com

Contact person for scientific queries

Name

Assoc. Prof Khalafallah

Address

Department of Haematology
Launceston General Hospital
Charles Street
Launceston Tas 7250

Country

Australia

Phone

+610417324623

Fax

+6103 63487133

alhossain@yahoo.com

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.

Trial Review

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Documents added manually

Documents added automatically