Actively Recruiting

Age: 18Years +
All Genders
NCT06683157

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

Led by Stadtisches Klinikum Dresden · Updated on 2024-11-21

250

Participants Needed

1

Research Sites

380 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Städtisches Klinikum Dresden

Dresden, Saxony, Germany, 01067

Actively Recruiting

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Research Team

S

Sebastian M. Schellong, Prof. Dr.

CONTACT

M

Mirko Brudzinski

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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