None listed
Conditions
Brief summary
This trial is a research study into an alternative treatment for calf vein blood clots (Deep Vein Thrombosis).The purpose is to investigate whether treatment with Enoxaparin produces better outcomes than standard treatment with Warfarin. We will be looking at how much of the time patients are receiving optimal doses of each of the drugs (therapeutic dose), patient satisfaction with each of the treatments and the costs associated with each of the treatments. The patients who participate in this trial will be ‘randomised’ to receive either; 1. Warfarin treatment group: Patients receive tablets of Warfarin but you will also receive Enoxaparin (fine needle injections) for the first few days while their body adjusts to Warfarin. The dose of Warfarin needs to be customised for each patient. This is done with blood tests called INR tests every few days to start with and then once per week or once per fortnight depending how your body responds to the warfarin. This is standard treatment and will probably be managed by their general practitioner (GP). 2. Enoxaparin group: patients assigned to the Enoxaparin group will receive daily injections with a very fine needle into the skin of their abdomen or legs. Most patients will be able to learn to give themselves these injections. Alternatively we could teach a friend or relative to give them to the patient, or in some cases we may be able to provide someone to come to their house to give them the injections. We think that treatment of symptomatic calf Deep Vein Thrombosis with enoxaparin may result in a higher chance of receiving therapeutic treatment (resulting from their being less variability in how patients bodies respond to be drug), a higher level patient satisfaction due to the decreased number of doctors visits, blood tests and dietary restrictions, and lower costs to the health care system than treatment with warfarin.
Interventions
At least 6 weeks with subcutaneous enoxaparin only, dosage 1.5mg/kg daily. Duration of treatment will be determined by the treating physician in accordance with American College of Chest Physicians (ACCP) and National Health and Medical Research Council (NHMRC) Guidelines with consideration of individual patient clinical profile and risk factors and the results of follow up ultrasound. Most patients will receive treatment for three months.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Consenting adult patients with symptomatic isolated calf vein (infra-popliteal) DVT as demonstrated with a positive ultrasound.
Exclusion criteria
1. Pregnancy and breast feeding 2. Associated pulmonary embolism (PE) or proximal DVT 3. Known hypersensitivity to heparin 4. Thrombocytopenia (baseline platelets less than 50x10 9L) 5. Impaired renal function (baseline eGFR less than 30) 6. Presence of active bleeding or a pathology susceptible to bleeding in the presence of anticoagulant 7. Significant Liver Disease (baseline INR greater than 1.5) 8. Treatment with warfarin is contraindicated 9. Active malignancy 10. Inability or unwillingness of patients to complete English questionnaires or maintain a diary 11. Necessity to receive anticoagulants for an indication other than calf vein thrombosis
Outcome results
None listed