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A Pilot study, for mandatory Venous Thromboembolism (VTE) Risk Assessment and Prophylaxis Implementation for cost effectively improving VTE outcomes in hospitalized medical patients

A Pilot study, mandatory Venous Thromboembolism (VTE) Risk Assessment and Prophylaxis Implementation for cost effectively improving VTE outcomes in hospitalized medical patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610001001088
Acronym
RAPI-Med Pilot Study
Enrollment
360
Registered
2010-11-17
Start date
2009-12-23
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 Ameri

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.

Sponsors

Clinical Trials Unit, St George Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Hospital medical inpatient admissions

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026