DVT of the calf / below knee region. MedDRA version: 12 Level: LLT Classification code 10013878 Term: DVT of calf
Conditions
Interventions
Product Name: Warfarin
Product Code: Warfarin
Pharmaceutical Form: Tablet
INN or Proposed INN: Warfarin
CAS Number: 81-81-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration
Sponsors
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All ambulatory outpatients presenting to Manchester Royal Infirmary Emergency department diagnosed with below knee calf vein thrombosis by vascular USS and able to give informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hospitalised patients. Patients on long term anticoagulation. Associated proximal DVT or confirmed PE. Contraindication to anticoagulation (active bleeding, recent haemorrhagic CVA or upper GI bleed). Other indication for immediate warfarinisation as per BSH guidelines: Prior confirmed and treated above knee DVT/PE, antiphospholipid syndrome, symptomatic inherited thrombophilia. Pregnancy. Chronic non propagating thrombus seen on prior USS. Previous enrollment to the ACT study and achievement of the primary outcome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with a deep vein thrombosis (blood clot) below the level of the knee, do the benefits of anticoagulant (blood thinning) therapy outweigh the risks. To quantify this, our primary research objective will look at whether treatment of below knee deep venous thrombosis with anticoagulation results in a reduced rate of clot extension or travel to the lungs. This is a primary feasibility trial initially. We aim to address the above question by looking at a small group of patients, in order to determine whether it would be feasibile to perform a definitive trial with large patient numbers. ;Secondary Objective: Does treatment of below knee deep venous thrombosis with anticoagulation result in increased rates of major or minor bleeding episodes. Does treatment of below knee deep venous thrombosis with anticoagulation (blood thinning medication) reduce the occurrence rate or severity of later problems related to chronic blood clots, such as post thrombotic syndrome, after two years. Does treatment of below knee deep venous thrombosis with anticoagulation (blood thinning medication) reduce the occurrence of a repeat blood clot developing in either limb over a two year period from the original presentation. ;Primary end point(s): Combined Incidence of thrombus propagation above knee or development of pulmonary embolism during the 3 months randomisation period will constitute the main primary outcome. This feasibility trial will look to establish the percentage of recruitable patients from available cohort and feasibility of maintaining treatment allocation for three months. | — |
Countries
United Kingdom
Outcome results
None listed