Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000330347
Ethics application status
Approved
Date submitted
4/07/2008
Date registered
15/07/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI): a pilot observational study
Scientific title
The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI) admitted to intensive care: a pilot observational study
Secondary ID [1] 620 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb deep venous thrombosis 2907 0
Condition category
Condition code
Cardiovascular 3548 3548 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients shall have ultrsonography and a thromboelastogram (blood test) performed on admission and thence every four days until death or discharge from the intensive care unit (ICU). The ultrasonography examination will take approximately 20 minutes. Patients will remain in the study whilst in the ICU.
Intervention code [1] 2634 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3924 0
Rate of lower limb deep venous thrombosis in traumatic brain injury patients admitted to intensive care during their stay in intensive care. This will be measured by means of a twice weekly venous ultrasound of both lower limbs.
Timepoint [1] 3924 0
The outcome will be measured within 72 hours of admission to intensive care and twice weekly thereafter until discharge from intensive care or death in intensive care.
Secondary outcome [1] 6599 0
The development of a hypercoaguable state will be measured by means of a specialised blood test called a thromboelastogram.
Timepoint [1] 6599 0
The outcome will be measured within 72 hours of admission to intensive care and twice weekly thereafter until discharge from intensive care or death in intensive care.

Eligibility
Key inclusion criteria
(1) Patients with TBI who are admitted to ICU (Glasgow Coma Scale <15), (2) age > 18 years, (3) no longer than 48 hours since primary traumatic injury, (4) expected to remain at least 96 hours in ICU.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Pregnancy or lactation, (2) inability to perform lower limb ultrasounds, (3) lack of consent, (4) enrolment in another trial.

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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3454 0
Charities/Societies/Foundations
Name [1] 3454 0
Tattersalls Foundation and the National Trauma Research Institute
Country [1] 3454 0
Australia
Primary sponsor type
University
Name
Australian and New Zealand Intensive Care Research Centre, Department of Epidemiology and Preventive Medicine, Monash University
Address
Level 3, 89 Commercial Road
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 3097 0
None
Name [1] 3097 0
Address [1] 3097 0
Country [1] 3097 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5482 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 5482 0
The alfred
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 5482 0
Australia
Date submitted for ethics approval [1] 5482 0
03/04/2008
Approval date [1] 5482 0
02/06/2008
Ethics approval number [1] 5482 0
89/08
Ethics committee name [2] 5628 0
Alfred Hospital Ethics Committee
Ethics committee address [2] 5628 0
Ethics committee country [2] 5628 0
Date submitted for ethics approval [2] 5628 0
Approval date [2] 5628 0
02/06/2008
Ethics approval number [2] 5628 0

Summary
Brief summary
Patients who are admitted to the intensive care unit with traumatic brain injuries (TBI) are at a significant risk of developing blood clots in their legs because (1) they are immobile, (2) their blood clots more quickly (part of the stress response to TBI) and (3) they tend not to be prescribed anti-clotting medication as they are at risk of further bleeding into their brain. About 30% of blood clots in the lower leg extend into the thigh and if untreated half of these will travel to the lung. Of those clots that travel to the lung 25% cause death. There is no current Australian or international data concerning the rate of blood clots in the legs in TBI. We plan to assess all patients with TBI on admission to the intensive care unit for blood clots by performing an ultrasound of their legs and repeating this twice weekly until discharge.
We also plan to determine each participant’s propensity to develop clots: this shall be done by performing a blood test (1 teaspoon) called a thromboelastogram and these tests shall be done whenever a patient has an ultrasound.
The results of the study will provide currently unknown data regarding the rate of lower limb blood clots in this at risk population. This in turn will help in the design of a future clinical trial comparing different clot prevention strategies in these patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28424 0
Address 28424 0
Country 28424 0
Phone 28424 0
Fax 28424 0
Email 28424 0
Contact person for public queries
Name 11581 0
Dr Andrew Westbrook
Address 11581 0
Level 3, 89 Commercial Road
Melbourne, VIC 3004
Country 11581 0
Australia
Phone 11581 0
+61 (0)3 99030280
Fax 11581 0
+61 (0)3 99030071
Email 11581 0
[email protected]
Contact person for scientific queries
Name 2509 0
Dr Alistair Nichol
Address 2509 0
Level 3, 89 Commercial Road
Melbourne, VIC 3004
Country 2509 0
Australia
Phone 2509 0
+61 (0)3 99030513
Fax 2509 0
+61 (0)3 99030071
Email 2509 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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