Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001255976
Ethics application status
Approved
Date submitted
4/12/2011
Date registered
7/12/2011
Date last updated
7/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of venous thromboembolic disease (VTE) in medical patients who presented to the Launceston General Hopspital (LGH)
Scientific title
Assessment of venous thromboembolic disease (VTE) in medical patients who presented to the Launceston General Hopspital (LGH)
Secondary ID [1] 273532 0
None
Universal Trial Number (UTN)
None
Trial acronym
VTE in Medical patients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism (VTE) among medical patients. 279333 0
Condition category
Condition code
Blood 279518 279518 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To assess the prevalence of venous thromboembolism (VTE) among medical patients.
Via assessment of all ulterasound or scans performed at the LGH for medical patients. The observation time is 6 months.
Intervention code [1] 283845 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286089 0
Venous thromboembolism (VTE).
Assessed by ultrasound or VQ-scan or CT-pulmonary angiogram
Timepoint [1] 286089 0
This timepoint will be assessed continously until the end of the study.
Secondary outcome [1] 295102 0
Assess risk factors of VTE
Via correlation with the international criteria of VTE-risk with clinical assessments as well as radiological findings and labortaory tests.
Timepoint [1] 295102 0
This timepoint will be assessed continously until the end of the study.

Eligibility
Key inclusion criteria
Medical patients with documented VTE from both sexes
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
30/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
986
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 284322 0
Hospital
Name [1] 284322 0
Launceston General Hospital
Country [1] 284322 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] 283266 0
None
Name [1] 283266 0
Address [1] 283266 0
Country [1] 283266 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286285 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 286285 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia
Ethics committee country [1] 286285 0
Australia
Date submitted for ethics approval [1] 286285 0
Approval date [1] 286285 0
24/10/2011
Ethics approval number [1] 286285 0
H12113

Summary
Brief summary
This study will investigate all medical patients who potentially at risk of developing blood clots (venous thrombo-embolism [VTE]) at any age group who are treated at the Launceston General hospital (LGH).

We will study all factors that may influence clot formation such as Age, Weight, Gender, Mobility, presence of co-morbidities, presence of cancer, Personal history of VTE, Family history of VTE, other risk factors for VTE, additional laboratory markers such as blood count, coagulation study.

The data of the trial will help to understand and know the risk factors for developing clots (VTE) among medical patients.

This trial has the potential to change the treatment approach and the preventive strategies for medical patients in order to improve outcome and benefit all patients avoiding a relatively common VTE-complications of the treatment.

This trial also reviewing the current protocols for prevention of VTE during the treatment of medical patients.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33486 0
Prof Alhossain A. Khalafallah
Address 33486 0
Launceston General Hospital Charles Street, Launceston, TAS 7250
Country 33486 0
Australia
Phone 33486 0
+61373487111
Fax 33486 0
+61373487695
Email 33486 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 16733 0
Prof A/Professor Alhossain A. Khalafallah
Address 16733 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Country 16733 0
Australia
Phone 16733 0
+61373487111
Fax 16733 0
+61373487695
Email 16733 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 7661 0
Prof A/Professor Alhossain A. Khalafallah
Address 7661 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Country 7661 0
Afghanistan
Phone 7661 0
+61373487111
Fax 7661 0
+61373487695
Email 7661 0
khalafallah@dhhs.tas.gov.au

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
SourceTitleYear of PublicationDOI
EmbaseVenous thromboembolism in medical patients during hospitalisation and 3months after hospitalisation: A prospective observational study.2016https://dx.doi.org/10.1136/bmjopen-2016-012346
N.B. These documents automatically identified may not have been verified by the study sponsor.