ATTRACT: Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis
|Principal Investigator: RussellVinik|
|Keywords: DVT - Deep Vein Thrombosis , Post-Thrombosis Syndrome , rt-PA Recombinant Tissue Plasminogen Activator , bleeding||Department: General Internal Medicine|
|IRB Number: 00038601||Co Investigator:|
|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.
Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
1. Age less than 16 years or greater than 70 years.
2. Symptom duration > 14 days for the current DVT episode (i.e. subacute or chronic DVT).
3. Established PTS in the ipsilateral leg, previous symptomatic DVT episode in the ipsilateral leg within the last 2 years, or recent (< 1 month) symptomatic DVT in the contralateral leg.
4. Presence of IVC filter with associated thrombus (acute or chronic), or DVT known to extend > 3 cm into the IVC (if a filter is present, the IVC should be imaged prior to randomization).
5. Limb-threatening circulatory compromise (i.e., phlegmasia cerulea dolens).
6. PE with hemodynamic compromise (i.e., hypotension).
7. Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
8. 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.
9. Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000/ml.
10. Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).
11. Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
12. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
13. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
14. 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.
15. Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
16. Pregnant (positive pregnancy test, women of childbearing age must be tested).
17. Recently (< 1 mo) had thrombolysis or is participating in another investigational drug study.
18. Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug in the last 7 days.
19. Life expectancy < 2 years or chronic non-ambulatory status.
20. Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).