Status:
COMPLETED
Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
McMaster University
Ontario Clinical Oncology Group (OCOG)
Conditions:
Deep Vein Thrombosis
Venous Thrombosis
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Symptomatic proximal DVT involving the iliac, common femoral, and/or femoral vein.
Exclusion
- 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).
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT00790335
Start Date
November 1 2009
End Date
January 1 2017
Last Update
March 29 2018
Active Locations (56)
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1
Arrowhead Hospital/Phoenix Heart, PLLC
Glendale, Arizona, United States, 85306
2
St. Joseph Hospital
Orange, California, United States, 92868
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Danbury Hospital
Danbury, Connecticut, United States, 06810