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Trial registered on ANZCTR
Registration number
ACTRN12620000666921
Ethics application status
Approved
Date submitted
7/05/2020
Date registered
11/06/2020
Date last updated
11/06/2020
Date data sharing statement initially provided
11/06/2020
Date results information initially provided
11/06/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does early chemical thromboprophylaxis and early mobilization increase the risk of bleeding complications in splenic trauma patients?
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Scientific title
Does early chemical thromboprophylaxis and early mobilization increase the risk of bleeding complications in splenic trauma patients?
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Secondary ID [1]
301220
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Splenic trauma
317376
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Condition category
Condition code
Injuries and Accidents
315477
315477
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Retrospective observational study for splenic trauma patients and timing of chemical thrombopropylaxis and mobilsation. Follow-up spans from time of injury until discharge and outpatient follow-up.
Data source: Gold Coast University Hospital electronic medical record.
No participant input, data collection only.
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Intervention code [1]
317521
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
323720
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Bleeding event
Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
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Assessment method [1]
323720
0
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Timepoint [1]
323720
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Inpatient admission
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Primary outcome [2]
323721
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Thromboembolic event
Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
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Assessment method [2]
323721
0
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Timepoint [2]
323721
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Inpatient admission
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Secondary outcome [1]
382719
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Blood product requirement
Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
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Assessment method [1]
382719
0
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Timepoint [1]
382719
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First 5 days of admission
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Eligibility
Key inclusion criteria
Splenic trauma
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Minimum age
5
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Operative or interventional radiology intervention for splenic trauma
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
A 5 year sample of splenic trauma patients.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
2/05/2018
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Date of last participant enrolment
Anticipated
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Actual
2/05/2018
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Date of last data collection
Anticipated
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Actual
2/05/2018
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Sample size
Target
85
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Accrual to date
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Final
85
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
16627
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Gold Coast University Hospital - Southport
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Recruitment postcode(s) [1]
30222
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4215 - Southport
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Funding & Sponsors
Funding source category [1]
305667
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Self funded/Unfunded
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Name [1]
305667
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N/A
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Address [1]
305667
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N/A
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Country [1]
305667
0
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Primary sponsor type
Hospital
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Name
Gold Coast University Hospital
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Address
1 Hospital Blvd, Southport, Queensland 4215
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Country
Australia
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Secondary sponsor category [1]
306078
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None
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Name [1]
306078
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N/A
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Address [1]
306078
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N/A
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Country [1]
306078
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305951
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Gold Coast Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
305951
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1 Hospital Blvd, Southport, Queensland 4215
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Ethics committee country [1]
305951
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Australia
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Date submitted for ethics approval [1]
305951
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Approval date [1]
305951
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01/05/2018
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Ethics approval number [1]
305951
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HREC/18/QGC/146
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Summary
Brief summary
Australian data on the management of chemical thromboprophylaxis (CTP) and mobilization in splenic trauma patients is limited. The authors review the outcomes of early CTP and mobilization practices in splenic trauma from a single institution. Retrospective review on the outcomes of splenic trauma patients based on timing of CTP and mobilization was conducted from April 2013 to April 2018. Data was collected on demographics, AAST injury grade, ISS, co-existing injuries precluding early CTP or mobilization, blood product requirement, bleeding events, and thromboembolic events.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
102182
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Dr Margaret Mansbridge
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Address
102182
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Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
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Country
102182
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Australia
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Phone
102182
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+61756870231
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Fax
102182
0
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Email
102182
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[email protected]
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Contact person for public queries
Name
102183
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Dr Margaret Mansbridge
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Address
102183
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Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
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Country
102183
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Australia
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Phone
102183
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+61 756870231
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Fax
102183
0
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Email
102183
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[email protected]
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Contact person for scientific queries
Name
102184
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Dr Margaret Mansbridge
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Address
102184
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Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
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Country
102184
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Australia
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Phone
102184
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+61 756870231
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Fax
102184
0
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Email
102184
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7886
Clinical study report
[email protected]
7887
Ethical approval
[email protected]
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.
Download to PDF