Observing the natural progression of isolated calf vein thrombosis
Natural History of Isolated Calf Vein Thrombosis - A Prospective Cohort Under Ultrasound Surveillance
Stadtisches Klinikum Dresden · NCT06683157
This study is testing how isolated calf vein thrombosis changes over time in patients who aren't taking blood thinners, to see if those medications are really needed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stadtisches Klinikum Dresden (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dresden, Saxony) |
| Trial ID | NCT06683157 on ClinicalTrials.gov |
What this trial studies
This study aims to understand the natural history of isolated calf vein thrombosis (ICVT) by monitoring patients through ultrasound surveillance without anticoagulation therapy. Patients with symptomatic ICVT will undergo comprehensive ultrasound examinations at specified intervals to assess the propagation of the thrombus. The study will evaluate the impact of various risk factors on the progression of ICVT, providing valuable insights into whether anticoagulation is necessary. By closely monitoring patients, the study seeks to ensure safety while gathering critical data on ICVT management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic isolated calf vein thrombosis confirmed by ultrasound.
Not a fit: Patients with prior unprovoked venous thromboembolism, active malignancy, or those requiring therapeutic anticoagulation for other reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more tailored and safer management strategies for patients with isolated calf vein thrombosis.
How similar studies have performed: While the approach of monitoring ICVT without anticoagulation is less common, similar observational studies have shown promise in understanding thrombus behavior.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dresden, Saxony
- Städtisches Klinikum Dresden — Dresden, Saxony, Germany (RECRUITING)
Study contacts
- Study coordinator: Sebastian M. Schellong, Prof. Dr.
- Email: sebastian.schellong@klinikum-dresden.de
- Phone: +493514801000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Embolism and Thrombosis of Calf Muscular Vein, Isolated Calf Vein Thrombosis, ultrasound surveillance