Trial Review

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
ACTRN12611000762954
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
21/07/2011
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of venous thromboembolic disease (VTE) in oncology and haematology patients who presented to the Launceston General Hospital for treatment of their malignant disorder
Scientific title
Assessment of venous thromboembolic disease (VTE) in oncology and haematology patients who presented to the Launceston General Hospital for treatment of their malignant disorder
Secondary ID [1] 262664 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
venous thromboembolic disease 268370 0
Malignant disorder 268374 0
Condition category
Condition code
Blood 268504 268504 0 0
Haematological diseases
Cancer 268509 268509 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will investigate all patients with cancer and develop blood clots at adult age group who are treated at the Launceston General Hospital (LGH) for their cancer during a period of 12 months. The data of the trial will help us enormously to understand and know the risk factors for developing clots among this high-risk group of patients.

This trial has the potential to change the treatment approach and the preventive strategies for cancer patients at all ages to improve outcome and benefit all patients avoiding serious complications of treatment of cancer.
Intervention code [1] 267010 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269247 0
To assess the prevalence of venous thromboembolism (VTE) among oncology and haematology patients who are treated at the Launceston General Hospital
Timepoint [1] 269247 0
12 months
Primary outcome [2] 269248 0
To document the treatment modalities or any other related data such as coagulation profile for these patients in order to correlate this with the outcome.
Timepoint [2] 269248 0
12 months
Secondary outcome [1] 279215 0
To determine the risk factors for venous thromboembolism (VTE) in these patients.
Timepoint [1] 279215 0
12 months

Eligibility
Key inclusion criteria
patients with hematological and malignant disorder who are over 18 years and presented with thromboembolic event to the Launceston General Hospital during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients below 18 years of age and who may present outside the study period range.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
766
Accrual to date
Final
766
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 267487 0
Hospital
Name [1] 267487 0
Launceston General Hospital
Country [1] 267487 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Fund
Address
Level 5,
Launceston General Hospital
Charles street
Launceston, Tasmania, 7250
Australia
Country
Australia
Secondary sponsor category [1] 266530 0
None
Name [1] 266530 0
Address [1] 266530 0
Country [1] 266530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269454 0
Tasmanian Human Ethics Committee
Ethics committee address [1] 269454 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Ethics committee country [1] 269454 0
Australia
Date submitted for ethics approval [1] 269454 0
Approval date [1] 269454 0
30/05/2011
Ethics approval number [1] 269454 0
H11708

Summary
Brief summary
Although most patients with different blood cancers and solid tumours present with clotting, there is little known about how many patients develop these complications and what risk factors are involved.

This study will investigate all patients with cancer and develop blood clots at adult age group who are treated at the Launceston General Hospital for their cancer. The data of the trial will help us enormously to understand and know the risk factors for developing clots among this high-risk group of patients.

This trial has the potential to change the treatment approach and the preventive strategies for cancer patients at all ages to improve outcome and benefit all patients avoiding serious complications of treatment of cancer.

This trial may able to change the current protocols for prevention of clots during the treatment of oncology patients by applying the best preventive strategy against blood clotting.

We are aiming to publish these data and the trial results in adequate international peer reviewed medical journal.
Trial website
Trial related presentations / publications
WH Heller, AA Khalafallah, RY Li, A Arora, M Latif, Sujana Nepal, Sue Wuong Loi, Daniel Grabek, Iain K Robertson. Modified Khorana risk score for prediction of venous thromboembolic events in cancer patients receiving chemotherapy: An Australian single institution experience. JOURNAL OF CLINICAL ONCOLOGY, 2013, Vol 31, issue 15 20/05/2013.
https://scholar.google.com.au/citations?view_op=view_citation&hl=en&user=7Ntik6EAAAAJ&cstart=20&citation_for_view=7Ntik6EAAAAJ:qwy9JoKyICEC
Public notes

Contacts
Principal investigator
Name 32897 0
Prof Professor Alhossain Khalafallah
Address 32897 0
Launceston General Hospital
Charles Street
TAS 7250 Australia
Country 32897 0
Australia
Phone 32897 0
+61367776777
Fax 32897 0
Email 32897 0
[email protected]
Contact person for public queries
Name 16144 0
Prof Assoc Prof. Alhossain Khalafallah
Address 16144 0
Launceston General Hospital,
Charles Street,
Launceston TAS 7250
Country 16144 0
Australia
Phone 16144 0
+61373487111
Fax 16144 0
+61373487695
Email 16144 0
[email protected]
Contact person for scientific queries
Name 7072 0
Prof Assoc Prof. Alhossain Khalafallah
Address 7072 0
Launceston General Hospital,
Charles Street,
Launceston TAS 7250
Country 7072 0
Australia
Phone 7072 0
+61373487111
Fax 7072 0
+61373487695
Email 7072 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.