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Trial registered on ANZCTR


Registration number
ACTRN12614000663651
Ethics application status
Approved
Date submitted
18/06/2014
Date registered
25/06/2014
Date last updated
25/06/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of pelvic and acetabular fractures with variable dose heparin for the prevention of pulmonary embolus.
Scientific title
The incidence of pulmonary embolus in patients with pelvic and acetabular fractures treated with variable dose heparin as prophylaxis to pulmonary embolus
Secondary ID [1] 284830 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary embolus 292215 0
Pelvic and acetabular fractures 292252 0
Condition category
Condition code
Blood 292551 292551 0 0
Clotting disorders
Injuries and Accidents 292593 292593 0 0
Fractures
Cardiovascular 292594 292594 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Variable dose unfractionated heparin, commencing 48 post injury, or post surgery, administered subcutaneously 8 hourly, according to a sliding scale based on APTT:
<24 +1000 units
24-28 +500 units
29-32 No change
33-37 - 500 units
>37 - 1000 units
Heparin ceased 8 hours pre-operatively. Heparin ceased one week post-operatively, once patient warfarinised.
Patients observed for any clinical evidence of pulmonary embolism, then confirmed with investigations (ventilation-perfusion lung scans early in the study and CT angiography or MRI angiography when those investigations became available)
Intervention code [1] 289622 0
Not applicable
Comparator / control treatment
Published results of the incidence of pulmonary embolus in patients with pelvic and acetabular fractures treated with fixed dose regimens of fractionated or unfractionated heparin - 1983-2005
Control group
Historical

Outcomes
Primary outcome [1] 292413 0
Clinical evidence of pulmonary embolus, investigated with ventilation-perfusion lung scans early in the study and CT angiography or MRI angiography when thosed investigations became available
Timepoint [1] 292413 0
Within 6 months of injury
Secondary outcome [1] 308894 0
Nil
Timepoint [1] 308894 0
Nil

Eligibility
Key inclusion criteria
Patients referred for treatments of pelvic and acetabular fractures and treated with variable dose unfractionated heparin as prophylaxis to pulmonary embolus
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients referred for treatment of pelvic and acetabular fractures and commenced on treatment with fixed dose regimens of fractionated or unfractionated heparin as prophylaxis to pulmonary embolus

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
All patients fulfilling inclusion criteria over 20 years.
This was an observational study commenced at onset as standard of care. When clinical observation indicated an inordinately low rate of pulmonary embolus, the prospectively collected data was reviewed retrospectively over a 20 year time period (1987-2007)

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)
SA
Recruitment hospital [1] 2656 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 289437 0
Hospital
Name [1] 289437 0
Royal Adelaide Hospital
Address [1] 289437 0
Frome Road
Adelaide
SA 5000
Country [1] 289437 0
Australia
Primary sponsor type
Individual
Name
Dr A.P.Pohl
Address
Discipline of Orthopaedics & Trauma
Level 4, Bice Building
Royal Adelaide Hospital
Frome Street
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 288127 0
Hospital
Name [1] 288127 0
Royal Adelaide Hospital

Address [1] 288127 0
Frome Road
Adelaide
SA 5000
Country [1] 288127 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291196 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 291196 0
Medical Administration
Level 3, Margaret Graham Building
Royal Adelaide Hospital
Frome Road
Adelaide
SA 5000
Ethics committee country [1] 291196 0
Australia
Date submitted for ethics approval [1] 291196 0
23/09/1998
Approval date [1] 291196 0
30/09/1998
Ethics approval number [1] 291196 0
980911

Summary
Brief summary
This was a prospective study of 369 consecutive patients referred to a single surgeon for treatment of pelvic and acetabular fractures over a 20 year period. All patients were treated with chemoprophylaxis using unfractionated heparin, according to a sliding scale, at an ‘antithrombotic’ dose. Treatment was withheld for 48 hours post-injury and 48 hours post-operatively, due to the risk of bleeding. Patients were fully anticoagulated with warfarin 7 days post-operatively when the risk of secondary bleeding was over. Patients with clinical evidence of pulmonary embolus (PE) were investigated with ventilation-perfusion lung scans early in the study and CT angiography or MRI angiography when those investigations became available.
Seven patients developed PE (1.9%). There was 1 fatal PE (0.3%)
CONCLUSION: Variable dose unfractionated heparin followed by warfarin offers excellent protection against PE compared to published results of fixed dose regimens using fractionated heparin or unfractionated heparin in patients with pelvic and acetabular fractures.
Trial website
Trial related presentations / publications
Public notes
This was an observational study commenced in 1987 at onset of my treatment of patients with pelvic and acetabular fractures. Data was collected propectively as standard of care. When clinical observation suggested an inordinately low rate of pulmonary embolus, ethics committee approval was sought for a study and data was reviewed retrospectively and data collection continued prospectively.

Contacts
Principal investigator
Name 49302 0
A/Prof Anthony Pohl
Address 49302 0
Discipline of Orthopaedics & Trauma
Level 4, Bice Building
Royal Adelaide Hospital
Frome Road
Adelaide
SA 5000
Country 49302 0
Australia
Phone 49302 0
+61 8 8222-5535/+61 (0)401123778
Fax 49302 0
+61 8 8232-3065
Email 49302 0
anthony.pohl@adelaide.edu.au
Contact person for public queries
Name 49303 0
A/Prof Anthony Pohl
Address 49303 0
Discipline of Orthopaedics & Trauma
Level 4, Bice Building
Royal Adelaide Hospital
Frome Road
Adelaide
SA 5000
Country 49303 0
Australia
Phone 49303 0
+61 8 82225535/+61 (0)401123778
Fax 49303 0
+61 8 8232-3065
Email 49303 0
anthony.pohl@adelaide.edu.au
Contact person for scientific queries
Name 49304 0
A/Prof Anthony Pohl
Address 49304 0
Discipline of Orthopaedics & Trauma
Level 4, Bice Building
Royal Adelaide Hospital
Frome Road
Adelaide
SA 5000
Country 49304 0
Australia
Phone 49304 0
+61 8 82225535/+61 (0)401123778
Fax 49304 0
+61 8 8232-3065
Email 49304 0
anthony.pohl@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary