Trial Review

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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
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 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
Sex
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
2/05/2018
Date of last participant enrolment
Anticipated
Actual
2/05/2018
Date of last data collection
Anticipated
Actual
2/05/2018
Sample size
Target
85
Accrual to date
Final
85
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
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
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
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
[email protected]
Contact person for public queries
Name 102183 0
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
[email protected]
Contact person for scientific queries
Name 102184 0
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
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7886Clinical study report  [email protected]
7887Ethical 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.