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Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by University Hospital Freiburg.
Recruitment status was:  Recruiting
Information provided by:
University Hospital Freiburg Identifier:
First received: May 13, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted


During the repair process of deep venous thrombosis, capillary formation is seen from day 18 to day 25. Contrast agent investigation is well known to detect small vessels in arterial disease. We intend to use this method to detect early vascularisation in the thrombus, in order to get more information about the evolution of the thrombosis in vivo.

Aims of the study:

Investigation of a newly diagnosed occluding venous thrombus with duplexsonography, using contrast agent and compare the degree of vascularization in the same patient after 3 weeks and 3 months. The relative signal intensity difference (baseline to peak) of the time intensity curve (TIC) is measured in defined region of interests (ROI). Comparison of the visibility of revascularisation between color duplexsonography, power mode and contrast agent will be done.


Patients with venous thrombosis of the proximal limb veins (femoral or popliteal vein) will be investigated with ultrasound agent in supine position. 5 ml of the contrast agent sulfur hexafluoride is given intravenously into a vein of the dorsal foot. The measurements are done in a defined area, where the thrombus is fully occluding in color Doppler investigation. The regions of interest will be the vessel walls and the centre of the thrombus in cross section view. The signal intensities are measured at baseline and peak (in decibel) in the centre and in the peripheral part of the vein. 20 patients with acute deep venous thrombosis will be included in this pilot study and investigated at baseline, after 3 weeks and 3 months.

Previously (before contrast agent application), the veins are investigated with color - and power Doppler to test visibility in comparison to the contrast agent investigation.

Deep Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Venous Thrombus Investigation With Contrast Enhanced Ultrasound Imaging, a Follow up Study

Resource links provided by NLM:

Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • Vascularisation in thrombosis in patients with initially occluded veins, assessed with ultrasound contrast agent (relative difference between baseline and peak of the time intensity curve) [ Time Frame: 3 months ]

Estimated Enrollment: 31
Study Start Date: April 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Patients with symptoms of deep venous thrombosis less than for 2 weeks, with thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with a newly diagnosed occluding venous thrombus with duplexsonography and symptoms of deep venous thrombosis less than for 2 weeks.

Inclusion Criteria:

  • Age > 18 and < 80 years old
  • Given written informed consent
  • Patients with symptoms of deep venous thrombosis less than for 2 weeks Thrombus occluding without any reperfusion in color mode in the common femoral vein (CFV), the femoral vein (FV) or the popliteal vein (PV)

Exclusion Criteria:

  • Arterial occlusive disease
  • Acute myocardial infarction, symptoms of coronary artery disease
  • Pregnancy
  • History of stroke or transient ischemic attack
  • Arterial hypertension uncontrolled
  • Allergy to contrast media
  • Participation in another study
  • Right heart insufficiency (clinical assessment with jugular vein filling in 45° sitting position)
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Please refer to this study by its identifier: NCT00677846

University of Freiburg Recruiting
Freiburg, Baden Würtemberg, Germany, 79110
Contact: Christina R. Jeanneret-Gris, MD    41-61-436-2060 ext 2780   
Sponsors and Collaborators
University Hospital Freiburg
Principal Investigator: Christina R. Jeanneret-Gris, MD University of Freiburg
  More Information

Responsible Party: Prof. Dr. C. Hehrlein, Abteilung Innere Medizin III, Kardiologie u. Angiologie Identifier: NCT00677846     History of Changes
Other Study ID Numbers: 314/03
Study First Received: May 13, 2008
Last Updated: May 13, 2008

Keywords provided by University Hospital Freiburg:
contrast agent ultrasound, vein thrombosis, vascularization

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases processed this record on May 25, 2017