acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis

Conditions: Deep Vein Thrombosis; Venous Thrombosis; Postphlebitic Syndrome; Venous Thromboembolism; Post Thrombotic Syndrome

Summary: the purpose of this study is to determine if the use of adjunctive pharmacomechanical catheter directed thrombolysis, which includes the intrathrombus administration of rt-pa--activase (alteplase),can prevent the post-thrombotic syndrome(pts)in patients with symptomatic proximal deep vein thrombosis(dvt)as compared with optimal standard dvt therapy alone.

activase, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. previous studies have established the ability of rt-pa to lyse venous thrombus in patients with deep vein thrombosis (dvt), and suggest that successful rt-pa mediated thrombolysis can prevent the post-thrombotic syndrome (pts), a morbid, late complication of dvt that occurs in nearly 50% of patients. rt-pa is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. this method of rt-pa delivery, pharmacomechanical catheter-directed intrathrombus thrombolysis (pcdt),is thought to be safer, more effective, and more efficient than previous methods. the question of whether pcdt using rt-pa improves long-term dvt patient outcomes with acceptable risk and cost has not yet been addressed. the rationale for performing the attract trial is based upon: * the major burden of pts on dvt patients and the u.s. healthcare system * the association between rapid clot lysis and prevention of pts * the proven ability of rt-pa to dissolve venous thrombus in proximal dvt * recent advances in cdt methods which may lower bleeding risk * the major clinical controversy on whether cdt should be routinely used for first-line dvt therapy

Eligibility criteria:
inclusion criteria: * symptomatic proximal dvt involving the iliac, common femoral, and/or femoral vein. exclusion criteria: * age less than 16 years or greater than 75 years. * symptom duration \> 14 days for the dvt episode in the index leg (i.e., non-acute dvt). * in the index leg: established pts, or previous symptomatic dvt within the last 2 years. * in the contralateral (non-index) leg: symptomatic acute dvt a) involving the iliac and/or common femoral vein; or b) for which thrombolysis is planned as part of the initial therapy. * limb-threatening circulatory compromise. * pulmonary embolism with hemodynamic compromise (i.e., hypotension). * inability to tolerate pcdt procedure due to severe dyspnea or acute systemic illness. * allergy, hypersensitivity, or thrombocytopenia from heparin, rt-pa, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used. * hemoglobin \ 1.6 before warfarin was started, or platelets \< 100,000/ml. * moderate renal impairment in diabetic patients (estimated glomerular filtration rate \[gfr\] \< 60 ml/min) or severe renal impairment in non-diabetic patients (estimated gfr \< 30 ml/min). * active bleeding, recent (\< 3 mo) gi bleeding, severe liver dysfunction, bleeding diathesis. * recent (\< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, obstetrical delivery, or other invasive procedure. * history of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm. * active cancer (metastatic, progressive, or treated within the last 6 months). exception: patients with non-melanoma primary skin cancers are eligible to participate in the study. * severe hypertension on repeated readings (systolic \> 180 mmhg or diastolic \> 105 mmhg). * pregnant (positive pregnancy test, women of childbearing potential must be tested). * recently (\< 1 mo) had thrombolysis or is participating in another investigational drug study. * use of a thienopyridine antiplatelet drug (except clopidogrel) in the last 5 days. * life expectancy \< 2 years or chronic non-ambulatory status. * inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).

Keywords: deep vein thrombosis deep venous thrombosis post thrombotic syndrome blood clot thrombolysis tissue plasminogen activator rt-pa activase mechanical thrombectomy pharmacomechanical attract