Städtisches Klinikum Dresden
Dresden, Saxony, 01067, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT06683157
Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance
The treatment of ICVT is still controversial as conflicting international guideline strategies show. Evidence suggests that propagation rates of ICVT without risk factors are low. Unless ICVT propagates to proximal veins anticoagulation can safely been withheld, thereby avoiding a bleeding risk for the patient. However, the impact of different risk factors on propagation rates is not well understood. This gap in knowledge can only be filled by a natural history study of ICVT without anticoagulation. Since patients are safe as long as no propagation occurs close ultrasound surveillance is an adequate safety umbrella for the natural history study period. In addition, it provides an objective outcome measure to define the impact of risk factors.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
For the purpose of this study, ICVT is defined as any thrombus being present in the calf muscle veins and/or in the deep paired calf veins as long as they do not affect the confluence (trifurcation) area or the popliteal vein.
Patients presenting with symptomatic ICVT will be examined by CCUS for both legs (V1). Inclusion/exclusion criteria will be checked, and patients will be informed about the nature of the study. In case patients provide informed consent, no anticoagulation therapy is given. Compression stockings at the calf length will be prescribed for 30 days.
CCUS will be repeated on day 5±2 (V2), day 10±2 (V3), and day 30±4 (V4). If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Presence of symptomatic ICVT proven by CCUS
- Absence of proximal DVT or PE
- Age of 18 or older
- Outpatient and inpatient status
- Written informed consent
Exclusion criteria
- Bedridden patients
- Prior unprovoked VTE
- Active malignancy (diagnosis within the last 6 months, and/or incomplete resection, and/or ongoing radiotherapy or chemotherapy, and/or metastatic disease).
- Pregnancy
- Therapeutic anticoagulation therapy for reasons other than VTE
Treatment and study plan
not drug
Diagnostic TestPatients presenting with symptomatic ICVT will be examined by CCUS for both legs. Inclusion/exclusion criteria will be checked. No anticoagulation therapy is given. Compression stockings at the calf length will be prescribed for 30 days.
CCUS will be repeated on day 5±2, day 10±2, and day 30±4. If the ICVT has propagated into the trifurcation area, the popliteal vein, or into more proximal veins therapy will be implemented according to current guidelines for proximal DVT. If no propagation to proximal veins has occurred anticoagulation will be withheld further on.
Other names: ultrasound surveillance
Primary outcomes
-
Rate of proximal extension of DVT and / or pulmonary embolism, symptomatic or asymptomatic DVT
Time frame: Day 30
Proximal DVT has to be documented by CCUS as a new thrombus in the trifurcation area, the popliteal vein, or in more proximal deep veins. Non-fatal PE has to be documented as an intraluminal filling defect in CT pulmonary angiography, as an unequivocal perfusion defect in lung scintigraphy, preferably performed in SPECT technique, or, in case of hemodynamic compromise, by echocardiographic signs of right ventricular failure and/or direct thrombus visualization.
Study contacts
Contact information is provided by the study sponsor or research team.
Mirko Brudzinski
CONTACT
Sebastian M. Schellong, Prof. Dr.
CONTACT
Sponsors and collaborators
Lead sponsor
Stadtisches Klinikum Dresden
Other
Registry information
Important dates
- Study start
- 2017
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Nov 12, 2024
- Registry last updated
- Nov 21, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.