Distal (Calf) Deep-vein Thrombosis Clinical Trial
— CACTUS-PTSOfficial title:
Contention Alone Versus Anticoagulation for Symptomatic Calf Vein Thrombosis Diagnosed by Ultrasonography
Verified date | May 2018 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.
Status | Completed |
Enrollment | 260 |
Est. completion date | August 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and exclusion criteria, and they have signed an informed consent form. Exclusion Criteria: - Age less than 18 years - Previously objectively diagnosed DVT or PE - Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation) - Clinically suspected pulmonary embolism - Active cancer, receiving cancer treatment or cancer considered cured for <6 months - Ipsilateral or contralateral proximal DVT - Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...) - Pregnancy - Thrombocytopenia (platelet count < 100 g/l) - Impaired renal function (serum creatinine > 180 micromol/l or clearance to creatinine less than 30 ml/min) - Known hypersensitivity to heparin - Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (gastric ulcer, cerebral malignant disease...) - Treatment with daily NSAIDs (aspirin =160 mg/day permitted) - Body weight >115 kg or <40 kg - Treatment with therapeutic doses of anticoagulants for >2 days, corresponding to: 2 injections of LMWH if once daily therapeutic LMWH used; 3 injections of LMWH if twice-daily therapeutic LMWH used; 1 dose of oral vitamin K antagonist (e.g. warfarin) - Ongoing requirement for prophylactic dose thromboprophylaxis (e.g. acute post-op patient receiving thromboprophylaxis) - Enrolled in another clinical trial within previous 30 days - Inability or refusal to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton General Hospital | Hamilton | Ontario |
Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Ottawa General Hospital | Ottawa | Ontario |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
France | Montpellier University Hospital | Montpellier | Languedoc |
Switzerland | University Hospital of Geneva | Geneva |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Geneva | Canadian Institutes of Health Research (CIHR), Lady Davis Institute, Ministry of Health, France, Swiss National Science Foundation |
Canada, France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks | 6 weeks | ||
Primary | Rate of post-thrombotic syndrome (PTS) | Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale. | 1 year | |
Secondary | Individual components of the composite endpoint: distal DVT extension to proximal veins at 6 weeks and 90 days; PE at 6 weeks and 90 days | 6 weeks and 3 months | ||
Secondary | Major bleeding at 6 weeks and 90 days | 6 weeks and 3 months | ||
Secondary | Death at 6 weeks and 90 days | 6 weeks and 3 months | ||
Secondary | Serious adverse events at 6 weeks and 90 days | 6 weeks and 3 months | ||
Secondary | Generic and venous disease-specific Quality of Life scores | 1 year | ||
Secondary | PTS severity category | Can either be mild, intermediate, severe | 1 year |