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

NCT06683157 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2024-11-21

No results posted yet for this study

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.

Conditions

  • Acute Embolism and Thrombosis of Calf Muscular Vein

Interventions

DIAGNOSTIC_TEST

not 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.

Sponsors & Collaborators

  • Stadtisches Klinikum Dresden

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2024-11-14
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683157 on ClinicalTrials.gov