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Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Not Recruiting
Trial ID: NCT00790335
Purpose
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.
Official Title
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis--The ATTRACT Trial
Stanford Investigator(s)
Gloria Hwang, MD
Clinical Professor, Radiology
John D. Louie, MD
Clinical Professor, Radiology
Nishita Kothary, MD
Professor of Radiology (Interventional Radiology)
David Hovsepian, MD
Clinical Professor, Radiology
Donald Schreiber
Associate Professor of Emergency Medicine at the Stanford University Medical Center, Emeritus
Daniel Sze, MD, PhD
Professor of Radiology (Interventional Radiology)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Eligibility
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 < 9.0 mg/dl, INR > 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).
Intervention(s):
drug: Recombinant tissue plasminogen activator (rt-PA)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Kamil Unver
6507259810