Status:
COMPLETED
Ultrasound-enhanced Thrombolysis Versus Standard Catheter Directed Thrombolysis for Ilio-femoral Deep Vein Thrombosis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Venous Thrombosis
Postthrombotic Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Patients with deep vein thrombosis (DVT) of the ilio-femoral veins have increased risk for developing post-thrombotic syndrome (PTS) and recurrent venous thromboembolism compared to more distal DVT. T...
Detailed Description
Background Deep vein thrombosis (DVT) is a public health problem with an annual incidence of 1 per 1000. Besides the acute risk of potentially fatal pulmonary embolism or phlegmasia cerulea dolens, t...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Symptomatic proximal DVT involving the iliac and/or common femoral vein, confirmed by Duplex Sonography, Angio-CT, Angio-MRI or Phlebography
- Written informed consent
- Exclusion Criteria
- Age less than 18 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 post-thrombotic syndrome (PTS) or previous symptomatic DVT within the last 2 years.
- Limb-threatening circulatory compromise.
- PE with hemodynamic compromise (i.e., hypotension).
- Inability to tolerate catheter procedure due to severe dyspnea or acute systemic illness.
- Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR \> 2.0 and platelet count \< 100 000/mm3)
- Severe renal impairment (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, CPR, obstetrical delivery, or other invasive procedure.
- History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
- Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested or use a medically accepted method of birth control).
- Recently (\< 1 mo) had thrombolysis.
- Life expectancy \< 6 months or chronic non-ambulatory status.
- Participating in any other investigational drug or device study or previous enrollment in this study
- Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01482273
Start Date
November 1 2011
End Date
November 1 2014
Last Update
July 17 2015
Active Locations (1)
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1
Division of Clinical and Interventional Angiology, Swiss Cardiovascular Center, University Hospital and University of Bern
Bern, Switzerland, 3010