Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance

Recruiting now

Conditions studied: Acute Embolism and Thrombosis of Calf Muscular Vein

In brief

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.

Key facts

Study ID

NCT06683157

Run by

Stadtisches Klinikum Dresden

People needed

250

Starts

2017-09-18

Expected to finish

2024-12-31

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Städtisches Klinikum Dresden — Dresden, Saxony, Germany (enrolling)

Full record on ClinicalTrials.gov

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