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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?
Scientific title
Does early chemical thromboprophylaxis and early mobilization increase the risk of bleeding complications in splenic trauma patients?
Secondary ID [1] 301220 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Splenic trauma 317376 0
Condition category
Condition code
Injuries and Accidents 315477 315477 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 317521 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323720 0
Bleeding event

Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
Timepoint [1] 323720 0
Inpatient admission
Primary outcome [2] 323721 0
Thromboembolic event

Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
Timepoint [2] 323721 0
Inpatient admission
Secondary outcome [1] 382719 0
Blood product requirement

Data will be collected from hospital records (Gold Coast University Hospital electronic medical record).
Timepoint [1] 382719 0
First 5 days of admission

Eligibility
Key inclusion criteria
Splenic trauma
Minimum age
5 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Operative or interventional radiology intervention for splenic trauma

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
A 5 year sample of splenic trauma patients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
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)
QLD
Recruitment hospital [1] 16627 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 30222 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 305667 0
Self funded/Unfunded
Name [1] 305667 0
N/A
Address [1] 305667 0
N/A
Country [1] 305667 0
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Blvd, Southport, Queensland 4215
Country
Australia
Secondary sponsor category [1] 306078 0
None
Name [1] 306078 0
N/A
Address [1] 306078 0
N/A
Country [1] 306078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305951 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 305951 0
1 Hospital Blvd, Southport, Queensland 4215
Ethics committee country [1] 305951 0
Australia
Date submitted for ethics approval [1] 305951 0
Approval date [1] 305951 0
01/05/2018
Ethics approval number [1] 305951 0
HREC/18/QGC/146

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102182 0
Dr Margaret Mansbridge
Address 102182 0
Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
Country 102182 0
Australia
Phone 102182 0
+61756870231
Fax 102182 0
Email 102182 0
margaret.mansbridge@health.qld.gov.au
Contact person for public queries
Name 102183 0
Dr Margaret Mansbridge
Address 102183 0
Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
Country 102183 0
Australia
Phone 102183 0
+61 756870231
Fax 102183 0
Email 102183 0
margaret.mansbridge@health.qld.gov.au
Contact person for scientific queries
Name 102184 0
Dr Margaret Mansbridge
Address 102184 0
Gold Coast University Hospital,
1 Hospital Blvd, Southport, Queensland, 4215
Country 102184 0
Australia
Phone 102184 0
+61 756870231
Fax 102184 0
Email 102184 0
margaret.mansbridge@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7886 0
Clinical study report
Citation [1] 7886 0
Link [1] 7886 0
Email [1] 7886 0
margaret.mansbridge@health.qld.gov.au
Other [1] 7886 0
Attachment [1] 7886 0
Type [2] 7887 0
Ethical approval
Citation [2] 7887 0
Link [2] 7887 0
Email [2] 7887 0
margaret.mansbridge@health.qld.gov.au
Other [2] 7887 0
Attachment [2] 7887 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 8011 0
Presentation
Citation/DOI/link/details [1] 8011 0
Poster presentation at the 2018 RACS Combined Tasmanian Annual Scientific Meeting & Trauma
Symposium: “Does early chemical thromboprophylaxis in AAST III-V splenic trauma increase bleeding complications?”

Oral presentation at the Royal Australasian College of Surgeons 88th Annual Scientific Congress 2019: "Experiences with splenic embolisation at a trauma centre: A 5 year review"
Attachments [1] 8011 0
Results – basic reporting
Results – plain English summary