Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001001088
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
17/11/2010
Date last updated
17/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot study, for mandatory Venous Thromboembolism (VTE) Risk Assessment and Prophylaxis Implementation for cost effectively improving VTE outcomes in hospitalized medical patients
Scientific title
A Pilot study, mandatory Venous Thromboembolism (VTE) Risk Assessment and Prophylaxis Implementation for cost effectively improving VTE outcomes in hospitalized medical patients
Secondary ID [1] 251901 0
RAPIMED (Risk Assessment for Prophylaxis in MEDical patients)
Universal Trial Number (UTN)
Trial acronym
RAPI-Med Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thromboembolism in hospitalised medical patients 256529 0
Condition category
Condition code
Public Health 256627 256627 0 0
Health service research
Cardiovascular 257643 257643 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study will assess the feasibility and logistics of conducting a study to assess the efficacy and cost effectiveness of implementing mandatory venous thromboembolism (VTE) risk assessment and consequent guideline-dictated VTE prophylaxis, on the prevention of VTE in hospitalised medically ill patients. The study will randomise consecutive medically ill hospital admitted patients to a control group or an intervention group. The intervention group will be risk assessed according to American Collage of Chest Physicans (ACCP) guidelines and thence prescribed or not prescribed VTE prophylaxis according to ACCP recommendations. Patients in the control group will have no intervention and will thus receive standard care which may or may not include VTE risk assessment and prophylaxis. Patients in both groups will be followed up for 90 days from randomization for thrombotic events or death from any cause. Bleeding events during hospitalisation will be collected. VTE, bleeding and prophylaxis related costs will be estimated.
For all patients in the intervention group, their VTE risk will be assessed according to the ACCP guidelines within 24 hours of their admissions. On the basis of that risk assessment effort will be made to ensure that VTE prophylaxis is implemented and customised to be compliant with ACCP guidelines i.e.
1. If patient is assessed by ACCP guidelines as not high risk, prophylaxis will not be given
2. If patient is assessed by ACCP guidelines as ‘high’ risk AND has no contraindication to anticoagulant therapy, chemical prophylaxis (anticoagulant drug and dose determined by patient's doctor) will be given throughout hospitalisation
3. If patient is assessed by ACCP guidelines as ‘High’ risk AND has contraindication to anticoagulant therapy, mechanical prophylaxis will be implemented throughout hospitalisation.
Intervention code [1] 255742 0
Early detection / Screening
Intervention code [2] 255743 0
Treatment: Drugs
Comparator / control treatment
Standard Care: patients randomised to the standard arm will not have a risk assesment performed, or any intervention to the usual care.
Control group
Active

Outcomes
Primary outcome [1] 257517 0
To determine the number of patients it is possible to recruit
Timepoint [1] 257517 0
3 months
Primary outcome [2] 259635 0
To determine whether the patients recruited are generalisable to the whole population of admitted medical patients by conducting anonymous VTE and bleeding risk assessments on those patient who do not consent to study inclusion
Timepoint [2] 259635 0
3 months
Secondary outcome [1] 262739 0
Incidence of symptomatic VTE outcome events: DVT, PE
Timepoint [1] 262739 0
Patients will be followed for 90 days from randomisation
Secondary outcome [2] 262740 0
Incidence of bleeding events
Timepoint [2] 262740 0
Patients will be followed for 90 days from randomisation
Secondary outcome [3] 262741 0
To determine the extent of Hawthorne effect on the 'usual care' group.
Timepoint [3] 262741 0
Change in VTE prophylaxis prescribing habits will be assessed over the period of recruitment

Eligibility
Key inclusion criteria
Hospital medical inpatient admissions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted to psychatric, surgical and Paediatic wards,
Patients discharged on the day of admission.
Patients admitted for Deep Vein Thrombosis or Pulmonary Embolism treatment.
Patient or next of Kin refuses consent.
Patients currently on therapeutic anticoagulants. Warfarin Intravenous Heparin, fonadaprinux, rivaroxaban,darbigatran, and Aspirin 360mg/day or higher
Patients in palliative care, intensive care units and high dependancy units

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive hospital admissions with medical conditions will be screened and enrolled. Using randon number generation, patients will be randomly assigned to the control or intervention group. The allocation key will be maintained by an independent ' randomisation group'.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers have been generated by a computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2391 0
2229
Recruitment postcode(s) [2] 3433 0
2217

Funding & Sponsors
Funding source category [1] 256297 0
Hospital
Name [1] 256297 0
Clinical trials Unit, St George Hospital
Country [1] 256297 0
Australia
Primary sponsor type
Hospital
Name
Clinical Trials Unit, St George Hospital
Address
Gray St Kogarah, NSW 2217
Country
Australia
Secondary sponsor category [1] 251619 0
None
Name [1] 251619 0
Address [1] 251619 0
Country [1] 251619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258385 0
Human Research Ethics Committee - Central Network
Ethics committee address [1] 258385 0
St George Hospital
Gray St
Kogarah NSW 2217
Ethics committee country [1] 258385 0
Australia
Date submitted for ethics approval [1] 258385 0
Approval date [1] 258385 0
24/07/2009
Ethics approval number [1] 258385 0
HREC/09/STG/53

Summary
Brief summary
Venous thromboembolism (VTE) is a condition that hospitalized patients may be susceptible to and which results in blood clots forming in their legs or in their lungs. The study will examine whether less patients develop clots when a medical guideline is strictly adhered to.
VTE or blood clots may occur in patients in hospital because they are not moving around as much as usual or perhaps because they have other illnesses that put them at risk. To try and reduce your chance of developing blood clots during your hospital stay your doctors may treat you with a ‘blood thinning’ medication or they may arrange for you to wear special stockings. There is some controversy about which patients are most likely to benefit from these preventative measures and some new guidelines have been proposed to help doctors decide which patients to treat and who it is safe not to treat. The purpose of this study is to test whether these guidelines work better than the system that is currently in place for making this judgment.
Trial website
Trial related presentations / publications
Guidelines for venous thromboembolism prevention in hospitalised medical patients: a validation study pilot. Presented at the annual meeting of the Australasian Society of Thrombosis and Haemostasis, October 20, 2010
Public notes

Contacts
Principal investigator
Name 30647 0
Address 30647 0
Country 30647 0
Phone 30647 0
Fax 30647 0
Email 30647 0
Contact person for public queries
Name 13894 0
Dr Nicola Chapman
Address 13894 0
St George Clinical School
Clinical Science Building
The St George Hospital
Short Street
Kogarah NSW 2217
Country 13894 0
Australia
Phone 13894 0
+61 2 911325 82
Fax 13894 0
+61 2 9113 3998
Email 13894 0
[email protected]
Contact person for scientific queries
Name 4822 0
Prof Beng Chong
Address 4822 0
St George Clinical School
Clinical Science Building
The St George Hospital
Short Street
Kogarah NSW 2217
Country 4822 0
Australia
Phone 4822 0
+61 2 9113 2010
Fax 4822 0
Email 4822 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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