Status: Active, not recruiting
Keywords: DVT - Deep Vein Thrombosis , Post-Thrombosis Syndrome , rt-PA Recombinant Tissue Plasminogen Activator , bleeding
IRB Number: 00038601
Specialty: Vascular Surgery, Internal Medicine, General
Sub Specialties: Thrombosis
It has been suggested that Pharmacomechanical Catheter-Directed Thrombolysis (PCDT) in symptomatic patients with acute proximal deep vein thrombosis (DVT) reduces the occurrence of the Post-Thrombotic Syndrome (PTS) over standard therapy with anticoagulation alone. Current data is of poor quality and is mostly from registries and retrospective studies.
The Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis [ATTRACT] trial will help to determine if PCDT should be routinely used to treat proximal DVT. The trial is multi-center trial funded by the National Heart Lung and Blood institute. Patients with acute ileofemoral DVT will be randomized to received PCDT followed by anticoagulation vs. anticoagulation alone and will be followed for 24 months. Primary outcomes will be incidence of PTS at 24 months. Secondary outcomes will be: Severity of PTS, resolution of presenting DVT symptoms prevalence of valvular reflux and residual thrombus at 1 year, degree of clot lysis with PCDT,and cost-effectiveness.
Principle Investigator: Russell Vinik
Principle Department: General Internal Medicine