RecruitingNCT06683157

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


Sponsor

Stadtisches Klinikum Dresden

Enrollment

250 participants

Start Date

Sep 18, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTnot drug

Patients 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.


Locations(1)

Städtisches Klinikum Dresden

Dresden, Saxony, Germany

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NCT06683157