Clinical trial NCT06683157: Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance
Official title: Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Embolism and Thrombosis of Calf Muscular Vein
Keywords: Isolated Calf Vein Thrombosis
ultrasound surveillance
Lead sponsor: Stadtisches Klinikum Dresden
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with symptomatic ICVT will be examined by CCUS for both legs. Inclusion/exclusion criteria will be checked. No anticoagulation therapy is given.

Brief 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of proximal extension of DVT and / or pulmonary embolism, symptomatic or asymptomatic DVT
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
state: Sachsen
Study officials:
References: